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Field Technical Specialist (Philadelphia / Northeast)

 
Field Technical Specialist 
Philadelphia, PA
 
Hope is Here!
Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company’s Optimizer® Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany; Pearl River, N.Y.; and Willemstad, Curacao.  
 
There are 64 million patients struggling with Heart Failure worldwide.  When these Heart Failure patients continue to decline despite being on optimum pharmaceutical therapy, they lose hope.  The only options down the road are extremely invasive.  CCM therapy is an FDA Breakthrough designated solution that is minimally invasive and gives hope back to these patients. 
 
This is not a job, It is a MISSION to help the nearly one million patients (in the United States alone) who are struggling with heart failure and qualify for CCM therapy.  This requires a team of the best medical device and therapy awareness representatives in the world to educate the cardiology community. 
 
Our exclusive sales team is made up passionate of, collaborative, and dedicated professionals. Our approach is to work in true partnership with physicians, affiliated health professionals, and healthcare administrators – providing the consultation, technical expertise, and comprehensive support they need to best serve their patients and communities.  
 
If you’re up to the challenge, you’ll find plenty of rewards, support, and career development opportunities. We've created a high-performance culture, where performance is recognized and celebrated. What’s more, by working directly with patients and physicians you’ll witness firsthand the immediate and positive impact you have on individual lives.  
 
The Field Technical Specialist (FTS) is responsible for supporting the departmental goals and objectives of Technical Operations, as well as internal/external customers with specialized technical training on procedural applications of Impulse Dynamics products. The FTS will be heavily involved in providing implant and follow-up support for commercial and clinical study purposes. The FTS will also provide coverage for procedures and follow-ups in accounts without existing or certified Territory Managers and accounts where clinical studies require specific Technical Operations personnel.
 
How You’ll Add Value
  • Cover cases (commercial and clinical)
  • Complete study-related paperwork (CRF, worksheets, etc.) for implants and follow-ups
  • Provide technical and administrative support when required for clinical studies and scientific studies. This may include a collection of patient data, support clinical sites, and/or patient support.
  • Leverage strong administrative skills to ensure all necessary paperwork associated with implant and follow-up or associated with data collection for clinical/scientific studies is correct.
  • Receive direction from Technical Operations leadership regarding case assignments and scheduling
  • Support after-hour patient hotline and technical services calls
  • Provide in-service training to physicians, nursing, and technical hospital staff
  • Maintain a comprehensive product and technical knowledge of all Impulse and competitive Cardiac Rhythm Management bradycardia and tachycardia products.
  • Maintain or obtain the International Board of Heart Rhythm Examiners (IBHRE) Certified Cardiac Device Specialist (CCDS) certification. FTS that are not certified on hire must become certified within two years of the hire date.
  • Assist the sales representative when asked to work with a specific sales territory
  • FTS is required to travel and provide implant support anywhere within the Associate Director of Technical Operations & Trainings territory globally.
  • Out-of-town travel is expected to be 75% but may fluctuate depending on the weekly needs of the business.
  • All other duties assigned by a Field Technical Trainer or their leadership.
  • Knowledge of Quality Management System.
  • Working knowledge of standards and regulations as outlined in the QMS documentation and structure.
  • Understanding that device defects may occur from the improper performance of specific job functions, including those personnel performing or participating in invalidations.
  • Each country has regulatory requirements which must be adhered to, which can impact individual roles within the company.
  • Understanding of individual role in achieving company quality objectives and QMS compliance.
What You’re Bringing with You
  • Bachelor’s degree or currently enrolled in a bachelor’s program with a completed pacemaker school certification required.
  • If FTS is currently working toward a bachelor's, FTS must maintain full coursework during employment and maintain a 3.0 or greater GPA to remain eligible for employment
  • Experience with customer-facing relationships including extensive experience with both physicians and patients.
  • Experience with operating room procedures, clinic, and surgical center protocols.
  • Valid driver’s license.
  • Ability to consistently travel an estimated 75% required – Including Weekends. Travel may fluctuate up or down based on the weekly needs of the business 
  • Ability to effectively communicate with personnel outside the U.S. in the spoken and written English language.
  • Ability to manage and coordinate multiple assignments effectively.
  • Ability to lift implant bag of approximately 40 lbs 
  • Ability to walk long distances, navigate airports with luggage and negotiate staircases with implant bags.
Our Commitment to You
Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that’s enjoyable, thorough, and fair. That’s our way of inspiring the innovative brightest minds.
 
Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around a diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference.
 
Equal Opportunity Employer Statement:
Impulse Dynamics is an equal opportunity employer.
 
Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.
 
 
 
 
 

Electrical Engineer

Electrical Engineer
Marlton, NJ
 
Hope is Here!
Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company’s Optimizer® Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany; Pearl River, N.Y.; and Willemstad, Curacao.  
 
Our Product Development team translates new and creative ideas into ground-breaking implantable medical devices which enormously benefit our patients.  We are looking for talented engineering professionals to bring their passion and dedication to our team to help introduce innovative products to market in record time.  As a member of our team, you will solve challenging problems to design and build medical products that truly change people’s lives.  You will have the exciting opportunity to work along with other knowledgeable engineers who are grounded in integrity, have a strong capacity to collaborate, and have the energy to get things done. If you are a committed and enthusiastic engineer, we invite you to bring your experience and talent to our team.
 
How You’ll Add Value
  • Design analog and embedded electronic circuit assemblies for market-destined products and internal development tools
  • Capture schematics and layout printed circuit boards
  • Specify or develop firmware for testing and internal development tools
  • Assemble and bring up prototype circuit assemblies
  • Coordinate technical aspects of projects with other group engineers, as well as with external development groups
  • Conduct development activities on multiple simultaneous projects
  • Thoroughly test and document work to the standard necessary for regulatory submission
  • Some experience developing firmware preferred.
  • Prior experience developing medical devices or instrumentation or working in other high reliability and/or heavily regulated fields preferred
What You’re Bringing with You
  • 3+ years of experience in a hands-on research and development work environment (substantial academic research may be considered as equivalent)
  • Ability to function well in a self-driven, start-up-like environment and balance multiple projects.
  • Primary experience designing analog and embedded electronics
  • Experience using electronic test equipment for the development and test of electronics.
  • Strong communication abilities in English
  • Bachelor’s or graduate degree in Electrical Engineering, or equivalent work experience
 
Our commitment to you
Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that’s enjoyable, thorough, and fair. That’s our way of inspiring the innovative brightest minds.
 
Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around a diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference.
 
Equal Opportunity Employer Statement:
Impulse Dynamics is an equal opportunity employer.
 
Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.
 
 

Junior Territory Manager (Lower Saxony & Schleswig-Holstein)

Junior Territory Manager
Lower Saxony & Schleswig-Holstein
 
Hope is Here!
Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company’s Optimizer® Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany; Pearl River, N.Y.; and Willemstad, Curacao.  
 
There are 64 million patients struggling with Heart Failure worldwide.  When these Heart Failure patients continue to decline despite being on optimum pharmaceutical therapy, they lose hope.  The only options down the road are extremely invasive.  CCM therapy is an FDA Breakthrough designated solution that is minimally invasive and gives hope back to these patients. 
 
This is not a job, it is a MISSION to help the nearly one million patients (in the United States alone) who are struggling with heart failure and qualify for CCM therapy.  This requires a team of the best medical device and therapy awareness representatives in the world to educate the cardiology community. 
 
Our exclusive sales team is made up passionate of, collaborative, and dedicated professionals. Our approach is to work in true partnership with physicians, affiliated health professionals, and healthcare administrators – providing the consultation, technical expertise, and comprehensive support they need to best serve their patients and communities.  
 
If you’re up to the challenge, you’ll find plenty of rewards, support, and career development opportunities. We've created a high-performance culture, where performance is recognized and celebrated. What’s more, by working directly with patients and physicians you’ll witness firsthand the immediate and positive impact you have on individual lives.  
 
How You’ll Add Value
  • Accountable for the sales development within his/her designated territory.
  • The leadership of the Sales Process in the Territory.
  • Opens new implanting centers and develops additional business at existing centers within his designated territory.
  • Works with both the clinical and administrative departments of the hospital.
  • Assists in the implant and conducts follow-up visits when necessary.
  • The leadership of the Sales Process in the Territory.
  • Opens new implanting centers and develops additional business at existing centers within his designated territory.
  • Works with both the clinical and administrative departments of the hospital.
  • Assists in the implant and conducts follow-up visits when necessary.
  • Area budget responsibility
  • Successfully acquiring new customers and opening new implanting centers
  • Establishing and developing stable, long-term customer relationships
  • Existing customer and new customer care
  • Conception and implementation of screening programs in hospitals and outpatient practices
  • Optimal planning and reporting of customer visits
  • Recruitment of new Study-Center – Registry and HF, monitoring of the implementation
  • Implantation support, follow-Up, and Trouble-Shooting
  • Training new employees
  • Contact development to ICD-patient self-help group
  • Develops additional business at existing centers within designated territory
  • Conducts follow-up visits when necessary
  • The job may at times require extensive travel and long hours.
  • Excellent interpersonal skills
  • Proven ability to develop new business and maintain strong business relationships
  • Excellent oral and written communications skills; working knowledge and understanding of the financial aspects of structuring an agreement. Organized/detail-oriented
  • Ability to provide technical support to implantation and follow-up visits.
  • Fluency in English
  • Bachelor’s degree required. Advanced degree in engineering or business preferred.
  • Knowledge and at least 3 years of experience in the cardiac device business are preferred.
 
What You’re Bringing with You
  • Bachelor’s degree required. Advanced degree in engineering or business preferred.
  • Knowledge and at least 3 years of experience in the cardiac device business are preferred.
 
 Our Commitment to You
Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that’s enjoyable, thorough, and fair. That’s our way of inspiring the innovative brightest minds.
 
Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around a diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference.
 
Equal Opportunity Employer Statement:
Impulse Dynamics is an equal opportunity employer.
 
Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.

Senior Technical Accounting Manager

Senior Technical Accounting Manager
Marlton, NJ
 
Hope is Here!
Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company’s Optimizer® Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe.   
 
Our corporate teams are an essential part of our company, ensuring that we're setting our businesses, clients, customers, and employees up for success.

The Senior Technical Accounting Manager supports the assistant and corporate controllers in all aspects of internal, external, and regulatory reporting. This position will interact extensively with SEC, NYSE, external auditors, and other accounting/tax service providers playing a critical role in the timely and accurate reporting and filing of ID’s financial results. The role will also service as a technical accounting expert responsible for leading application US GAAP/IFRS and other guidelines. The role will assist with tax, SOX, and other compliance and special projects as directed by management.

In addition, the STAM will assist Financial Planning & Analysis for expeditious and accurate business planning and analysis including financial metrics and dashboards

How You’ll Add Value

  • Assist in an effective, optimized, coordinated and consistent efforts in the application of US GAAP (IFRS), NYSE/NASDAQ (or similar), banking and other rules to the financial reporting of ID-including fast and accurate monthly closing processes.

  • Working with outside service providers leading to successful completion quarterly reviews, annual audits, statutory filings, and other deliverables including important and extensive “PBC” schedules supporting the activities listed

  • Assist tax, SOX, and other compliance efforts in accurate and timely manner while maintaining a secure internal control environment and corporate enterprise risk management

  • Assist in preparing and filing all necessary financial reports and SEC reports (if, when applicable) ensuring accuracy and conformance

  • Be a key strategic leader supporting reporting and dissemination of financial data cross functionally across many systems and platforms

  • Assist company in translation, application, and implementation of emerging or new accounting pronouncements serving as a technical accounting expert including managing other third-party technical accounting experts

  • Liaison across the organization articulating and communicating accounting, financial, tax, or other financial matters in “plain English” to parties outside of accounting and finance

  • Other duties as directed by management

What You’re Bringing with You

  • Bachelor’s Degree in Accounting, Business Administration, or other related field

  • 3+ years of technical accounting experience with strong bias towards large public accounting experience

  • Excellent written and verbal communication skills, with proven ability to work effectively with all levels of the organization; and manage relationships with outside parties, especially technical accounting expert

  • Strong professional demeanor

  • Strong organizational skills, attention to detail, and follow-up skills.

  • Demonstrated ability to manage multiple priorities and be flexible in responding to changing business demands including supporting a fast-paced, experienced senior management team

  • Ability to maintain confidentiality and act with discretion.

  • Strong computer skills, including proficiency in Microsoft Office and experience with ERP and/or database systems.

  • MBA or Masters Accounting & Certified Public Accountant designate not required, but are a plus

 
Our Commitment to You
Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that’s enjoyable, thorough, and fair. That’s our way of inspiring the innovative brightest minds.
 
Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around a diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference.
 
Equal Opportunity Employer Statement:
Impulse Dynamics is an equal opportunity employer.
 
Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.

 
 

 

Operations Accountant

Operations Accountant
Marlton, NJ
 
Hope is Here!
Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company’s Optimizer® Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany; Pearl River, N.Y.; and Willemstad, Curacao.  
 
Our corporate teams are an essential part of our company, ensuring that we're setting our businesses, clients, customers, and employees up for success.
 
The Operations Accountant is responsible for working cross-functionally with the Operations team on proper accounting application and analysis and key accounting deliverables in support of monthly and quarterly close processes. Responsibilities include recording entries, preparing schedule, asset management, support of the Company’s internal controls structure and ad hoc analyses, as assigned.
 
How You’ll Add Value

  • Assist with monthly financial close processes.

  • Work on site at other ID locations including suppliers and potentially Internally

Work proactively with our operations/product development staff (s) in globally on a variety of topics including but not limited to:  o Costing   o Physical Inventory / Cycle Counts o New product bill of materials and mapping o Inventory management o Fixed asset management o Labor analysis (rates) o Supplier and contractor management

  • Responsible for timely and accurately recording all entries in accordance with the corporate closing and schedule SOX 404 policies.

  • Liaise with IT on Business Central configuration and control

  • Assist with the integration of acquisitions into ERP system

  • Assist the Accounts Receivable and Accounts Payable team with day-to-day transactions and system related trouble shooting

  • Employ a “continuous improvement” mindset and proactively seek and implement process or system related improvements or enhancements that result in efficiency and/or increased control and reliability.

  • Prepare schedules to support journal entries and general ledger account reconciliations.

  • Prepare schedules to support quarterly reviews and annual audits.

  • File and remit taxes and other financial obligations.

  • Assist with accounting policy and procedure documentation.

  • Perform other duties, as assigned, including support of International operations

What You’re Bringing with You

  • Bachelor's Degree in Accounting.

  • Minimum of three to five years of related experience required.

  • ERP/system experience a plus.

  • General understanding of GAAP/IFRS principles.

  • Knowledge of internal control processes and procedures.

  • Excellent verbal and written communication skills, with demonstrated ability to work independently and as a team.

  • Strong analytical skills and detail-oriented.

  • Advanced Microsoft Excel skills, including the use of advanced functions to extract, summarize, and present data.

  • Experience with other Microsoft Office products, such as Word, Outlook, PowerPoint, etc.

  • Proven ability to prioritize, manage multiple projects, and meet deadlines.

  • Superior knowledge of cost accounting.

Our Commitment to You
Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that’s enjoyable, thorough, and fair. That’s our way of inspiring the innovative brightest minds.
 
Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around a diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference.
 
Equal Opportunity Employer Statement:
Impulse Dynamics is an equal opportunity employer.
 
Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.

 
 

 

EU Manager: Quality Assurance / Regulatory Affairs

EU Manager:  Quality Assurance / Regulatory Affairs
Frankfurt, Germany
 
Hope is Here!
Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company’s Optimizer® Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany; Pearl River, N.Y.; and Uruguay.  
 
How You’ll Add Value
The QA/RA EU Manager is responsible for providing technical leadership in establishing, implementing, and maintaining quality system processes and documentation in compliance with domestic and international regulatory/quality requirements.
  • Responsible for serving as the PRRC for Impulse Dynamics, Inc. USA and the EC Representative
  • Responsible for oversight and execution of logistics.
Quality
  • Assist in the development and authoring of quality system policy, procedures, and instructions.
  • Assist Director, Quality Assurance with management of multiple Quality Management System functions.
  • Oversees the day-to-day operations of the Quality Management System in EU-
  • REP/Importer/Distributor of Impulse Dynamics, Inc. USA.
  • Audits and collaborates with outsourced processes in the EU/International to ensure quality control of incoming product and outgoing shipments (inspection, labeling, inventory tracking)
  • Manages the preparation and assists with the execution of external and internal audits.
  • Oversee EU/International complaints to ensure proper completion of EU field complaints, complete complaint investigations and report adverse events to regulatory to ensure timely reporting to regulatory authorities.
  • Performs investigations of EU related non-conformances, customer complaints and corrective actions
  • Ensures the timely and effective follow up of all identified or assigned quality issue
  • Manages the activities for device safety testing
  • Liaison for Clinical Affairs with regards to Quality compliance information
  • Authorized representative for Radiation Protection (§69 StrlschG) Safety Officer (§30, MPG2)
  • Maintains and demonstrates understanding of global standards, regulations, and regulatory bodies to include but not limited to ISO 13485:2016, 21 CFR Part 820, 21 CFR Part 812, MDSAP and MDR
Training
  • Provides new employees training at the EU location (Welcome/Quality Training)
  • Provides field personnel training on regulatory and/or QA issues
Regulatory
  • Maintains/checks the regulatory status of countries
  • Assists in the application for Registration Documents
  • Checks for Import Licenses of customers
  • Applies for Free Sales Certificates
  • Responsible for documents stamped/legalized at the Chamber of Commerce/local court
  • Assists in the negotiation of quality agreements when required
  • Assists with local special features (Waste Management with Italy, GTIN database for Dubai/UAE, EUDAMED) § Contact for the Regional Board § Contact for BfArM (Federal Institute for Drugs and Medical Devices) and DIMDI (German Institute of Medical Documentation and Information)
  • Follow requirements outlined in the EU Authorized Representative (EUAR)/Importer/Distributor agreement with Impulse Dynamics corporate in the U.S.
  • Designated Person Responsible for Regulatory Compliance per the MDR 2017/745.
Logistics
  • Shipment of product to the field
  • Processing returns to the US § Patient replacement devices
  • Shipment of marketing materials upon request. § Ordering boxes for shipping
  • ERP Transactions for device movement for the QA/RA/Logistics position
  • Customs clearance submissions for international shipments
  • Inventory control
 
What You’re Bringing with You
  • Well-developed written and verbal communication skills.
  • Strong interpersonal skills and ability to work in a team environment.
  • Ability to take initiative
  • Ability to maintain confidentiality.
  • Superior organizational skills and ability to maintain deadlines.
  • BS in Engineering or Life Science Field required.
  • 5-10 years of QA/RA experience in a regulated environment (e.g., ISO 13485:2016, 21 CFR Part 820 and MDSAP)
  • Trained ISO 13485:2016 auditor preferred.
  • Knowledge of European Medical Device Regulations and ISO Standards
  • Proficient in German and English
 
Our commitment to you
Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that’s enjoyable, thorough, and fair. That’s our way of inspiring the innovative brightest minds.
 
Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference.
 
Equal Opportunity Employer Statement:
Impulse Dynamics is an equal opportunity employer.
 
Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.
 

Supplier Engineering Program Manager

Supplier Engineering Program Manager
United States - Remote
 
Hope is Here!
Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company’s Optimizer® Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany; Pearl River, N.Y.; and Willemstad, Curacao.  
 
There are 64 million patients struggling with Heart Failure worldwide.  When these Heart Failure patients continue to decline despite being on optimum pharmaceutical therapy, they lose hope.  The only options down the road are extremely invasive.  CCM therapy is an FDA Breakthrough designated solution that is minimally invasive and gives hope back to these patients. 
 

The Supplier Engineering Program Manager is responsible for applying diversified technical and management knowledge of Manufacturing, Operations and Quality exercising acumen of Supply Chain Management to plan, design, and optimize a subcontract outsource manufacturing model. The role identifies, recommends, and implements tactics to ensure minimum risk and maximum scale in support of Impulse Dynamics strategic growth plan.

How You’ll Add Value

  • As Program Manager, develops long term improvement strategies with suppliers. Validates supplier proposals for improvement, makes investment case, and manages implementation. Focuses on driving improvements in production thru automation and other techniques

  • Develops and drives a beneficial partnership model with suppliers based on continuous improvement methodologies that yields cost, quality, and service improvements

  • Assesses supply chain risk, develops risk mitigation strategies, and identifies and develops new suppliers as required by ongoing and future business needs

  • Program management of supplier’s manufacturing plant transfers and selection/qualification of new suppliers.

  • Develops scorecards, and leads ongoing supplier performance reviews. Collaborates on process improvement activity with suppliers to ensure industry leading quality and service

  • Collaborates with Design and Quality Engineering functions to investigate and resolve quality or compliance issues at suppliers.

  • Reviews and approves supplier documentation such as Standard Operating Procedures, Critical to Quality characteristics and Control Plans, Work Instructions.

  • Key stakeholder in early supplier involvement efforts, Design for Manufacturability (DFM), PPAP and is the key liaison between design engineering and the contract manufacturing supply chain.

  • Develops and maintains a technology and capacity roadmap that aligns with Impulse Dynamics New Product Development timeline and future revenue growth

  • Provides and solicits input to internal and external stakeholders for design, manufacturing, material specifications and manufacturing procedures to ensure that the resulting products can be adequately manufactured and tested.

  • Develops, writes and controls detailed work instructions

  • Communicates clearly. Responsible to ensure all parties understand the direction, status of all meetings, projects, and development. Utilizes metrics, dashboards, and standard reports to communicate status

What You’re Bringing with You
  • Bachelor's degree or advanced degree or equivalent required.
  • Minimum of 10 years’ experience in Supplier Management for medical devices
  • Knowledge of components and core manufacturing processes for CRM or equivalent devices
  • Knowledge of Lean Six Sigma concepts 
  • Experience with standard qualification standards and development tools such as Advanced Product Quality Planning (APQP), Production Part Approval Process (PPAP), Failure Mode and Effects Analysis (FMEA), Statistical Process Control (SPC) and Measurement System Analysis (MSA) for supplier development 2. Skills & Abilities
  • Track record of Program Management success including leadership, teamwork, collaboration, creativity, and innovation while effectively communicating across various levels of the organization
  • Strong analytical and problem solving skills.
  • Ability to establish collaborative working relationships cross-functionally internally as well as with a diverse supply base
  • Self-motivated, results oriented with strong written and verbal communication skills; ability to effectively prepare and deliver technical reports and presentations
 Our Commitment to You
Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that’s enjoyable, thorough, and fair. That’s our way of inspiring the innovative brightest minds.
 
Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around a diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference.
 
Equal Opportunity Employer Statement:
Impulse Dynamics is an equal opportunity employer.
 
Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.

 
 

Territory Manager- Bay Area

Territory Manager
San Francisco - Bay Area
 
Hope is Here!
Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company’s Optimizer® Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany; Pearl River, N.Y.; and Willemstad, Curacao.  
 
There are 64 million patients struggling with Heart Failure worldwide.  When these Heart Failure patients continue to decline despite being on optimum pharmaceutical therapy, they lose hope.  The only options down the road are extremely invasive.  CCM therapy is an FDA Breakthrough designated solution that is minimally invasive and gives hope back to these patients. 
 
This is not a job, It is a MISSION to help the nearly one million patients (in the United States alone) who are struggling with heart failure and qualify for CCM therapy.  This requires a team of the best medical device representatives in the world to educate the cardiology community. 
 
Our exclusive sales team is made up of passionate, collaborative, and dedicated professionals. Our approach is to work in true partnership with physicians, affiliated health professionals, and healthcare administrators – providing the consultation, technical expertise, and comprehensive support they need to best serve their patients and communities.  
 
If you’re up to the challenge, you’ll find plenty of rewards, support, and career development opportunities. We've created a high-performance culture, where performance is recognized and celebrated. What’s more, by working directly with patients and physicians you’ll witness firsthand the immediate and positive impact you have on individual lives.  
 
How You’ll Add Value
  • Leadership of the Sales Process in the Territory.
  • Opens new implanting centers and develops additional business at existing centers within his designated territory.
  • Works with both the clinical and administrative departments of the hospital.
  • Assists with implant and conducts follow-up visits when necessary.
  • Area budget responsibility.
  • Successfully acquiring new customers and opening new implanting centers.
  • Establishing and developing stable, long-term customer relationships.
  • Existing customer and new customer care.
  • Conception and implementation of screening programs in hospitals and outpatient practices.
  • Optimal planning and reporting of customer visits.
  • Recruitment of new Study-Center – Registry and HF, monitoring of the implementation.
  • Implantation support, follow-up, and troubleshooting.
  • Training new employees.
  • Contact development to ICD-patient self-help group.
  • Develops additional business at existing centers within a designated territory.
  • Conducts follow-up visits when necessary.
What You’re Bringing with You
  • Bachelor's degree or advanced degree or equivalent required.
  • 10 years of experience in the cardiac device industry is required.
  • Proven ability to develop new business and maintain strong business relationships.
  • Excellent oral and written communications skills; working knowledge and understanding of the financial aspects of structuring an agreement.
  • Ability to provide technical support to implantation and follow-up visits.
  • Ability to effectively communicate with personnel inside/outside the U.S. in the spoken and written English language.
  • Ability to manage and coordinate multiple assignments effectively.
 Our Commitment to You
Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that’s enjoyable, thorough, and fair. That’s our way of inspiring the innovative brightest minds.
 
Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around a diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference.
 
Equal Opportunity Employer Statement:
Impulse Dynamics is an equal opportunity employer.
 
Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.

 
 

Growth Marketing Manager

Growth Marketing Manager

Marlton, NJ (Fully Remote Position)

 

Hope is Here!

Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company’s Optimizer® Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany; Pearl River, N.Y.; and Willemstad, Curacao.

 

Our Market Activation team is expanding CCM awareness and launching creative campaigns to reach and engage with patients across the US. We are looking for a talented marketer to bring their passion and dedication to our team to help expand our reach across digital channels. As a member of our team, you will design, build, and analyze campaigns that will ultimately change people’s lives. You will have the exciting opportunity to work along with other knowledgeable digital practitioners who are grounded in integrity, have a strong capacity to collaborate, and have the energy to get things done. If you are a committed and enthusiastic digital marketer, we invite you to bring your experience and talent to our team.

 

How You’ll Add Value

· Execute media buys and campaigns in digital channels/platforms both directly in platform and potentially alongside an Agency partner, where you will provide expert insight & guidance

· Drive qualified leads across marketing acquisition channels with a focus on meeting goals for CAC, revenue, high-value customer demographics, and LTV

· Update and maintain budget, media mix, reporting, and forecasting through strategic & tactical planning

· Use a data-driven approach to both strategize and build campaigns that leverage multiple lead generation tactics and marketing channels - Analyze patient behavior data to maximize the effectiveness of existing patient acquisition initiatives and report results, insights, and recommendations to key stakeholders

· Lead regular reporting to senior leadership on marketing performance via KPIs such as Cost per Lead, Cost per Implant, and other similar metrics

· Develop end-to-end digital experiences and recommend website design optimization to drive patients further down the acquisition funnel with input and alignment from key functional leaders

· Collaborate productively with cross-functional teams inside and outside marketing to develop, execute, and champion high-impact marketing tests (including A/B creative testing, communication themes, etc.)

· Oversee digital attribution & measurement platforms and contribute to strategy around enhancing our technology stack and new opportunities through campaign trends, analysis, and industry insights to acquire high-quality patients

· Collaborate with Sales team to grow and maintain provider locator to help connect patients with providers who are advocates of CCM Therapy

· goals

·

· Leverage the capabilities of Marketing Cloud (Pardot) to create and maintain awareness of CCM therapy via targeted email nurture campaigns directed to current and potential providers who have either historically referred patients for therapy and/or who are caring for CCM eligible patients in their practices.

 

What You’re Bringing with You

· 3-5 years of related job experience in an advertising agency or start-up environment strongly preferred

· You have at least 1-3 years of experience building and executing user acquisition campaigns geared toward optimizing conversions and lead generation

· You are an analytical problem solver with a track record of success in developing and optimizing marketing and offer strategies and programs that drive customer acquisition 

· Bachelor’s degree in business, economics, digital marketing, or related field; MBA a plus  

· Hands-on experience & credentials with the Google Suite of Solutions (AdWords, Display Network, Google Tag Manager, Google Analytics, etc.), Facebook Business Manager, Social Networks, or other digital marketing, advertising, and enablement platforms

· A drive to combine media campaign execution with analysis and strategic thinking 

· Familiarity with data visualization tools like Tableau and Salesforce Dashboards

· A passion for a start-up environment and a strong belief that quickly testing, failing, and optimizing can lead to sustainable business results 

 

Our Commitment to You

Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that’s enjoyable, thorough, and fair. That’s our way of inspiring the innovative brightest minds.

 

Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around a diversity of thought and mutual respect. We lead with inclusion and empower our team members to

do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference.

 

Equal Opportunity Employer Statement:

Impulse Dynamics is an equal opportunity employer.

 

Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.

ID - 8a7885ac934bc762019388ad48ef581e

Field Technical Specialist (Philadelphia / Northeast)

Location: United States Philadelphia PA
Apply
 
Field Technical Specialist 
Philadelphia, PA
 
Hope is Here!
Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company’s Optimizer® Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany; Pearl River, N.Y.; and Willemstad, Curacao.  
 
There are 64 million patients struggling with Heart Failure worldwide.  When these Heart Failure patients continue to decline despite being on optimum pharmaceutical therapy, they lose hope.  The only options down the road are extremely invasive.  CCM therapy is an FDA Breakthrough designated solution that is minimally invasive and gives hope back to these patients. 
 
This is not a job, It is a MISSION to help the nearly one million patients (in the United States alone) who are struggling with heart failure and qualify for CCM therapy.  This requires a team of the best medical device and therapy awareness representatives in the world to educate the cardiology community. 
 
Our exclusive sales team is made up passionate of, collaborative, and dedicated professionals. Our approach is to work in true partnership with physicians, affiliated health professionals, and healthcare administrators – providing the consultation, technical expertise, and comprehensive support they need to best serve their patients and communities.  
 
If you’re up to the challenge, you’ll find plenty of rewards, support, and career development opportunities. We've created a high-performance culture, where performance is recognized and celebrated. What’s more, by working directly with patients and physicians you’ll witness firsthand the immediate and positive impact you have on individual lives.  
 
The Field Technical Specialist (FTS) is responsible for supporting the departmental goals and objectives of Technical Operations, as well as internal/external customers with specialized technical training on procedural applications of Impulse Dynamics products. The FTS will be heavily involved in providing implant and follow-up support for commercial and clinical study purposes. The FTS will also provide coverage for procedures and follow-ups in accounts without existing or certified Territory Managers and accounts where clinical studies require specific Technical Operations personnel.
 
How You’ll Add Value
  • Cover cases (commercial and clinical)
  • Complete study-related paperwork (CRF, worksheets, etc.) for implants and follow-ups
  • Provide technical and administrative support when required for clinical studies and scientific studies. This may include a collection of patient data, support clinical sites, and/or patient support.
  • Leverage strong administrative skills to ensure all necessary paperwork associated with implant and follow-up or associated with data collection for clinical/scientific studies is correct.
  • Receive direction from Technical Operations leadership regarding case assignments and scheduling
  • Support after-hour patient hotline and technical services calls
  • Provide in-service training to physicians, nursing, and technical hospital staff
  • Maintain a comprehensive product and technical knowledge of all Impulse and competitive Cardiac Rhythm Management bradycardia and tachycardia products.
  • Maintain or obtain the International Board of Heart Rhythm Examiners (IBHRE) Certified Cardiac Device Specialist (CCDS) certification. FTS that are not certified on hire must become certified within two years of the hire date.
  • Assist the sales representative when asked to work with a specific sales territory
  • FTS is required to travel and provide implant support anywhere within the Associate Director of Technical Operations & Trainings territory globally.
  • Out-of-town travel is expected to be 75% but may fluctuate depending on the weekly needs of the business.
  • All other duties assigned by a Field Technical Trainer or their leadership.
  • Knowledge of Quality Management System.
  • Working knowledge of standards and regulations as outlined in the QMS documentation and structure.
  • Understanding that device defects may occur from the improper performance of specific job functions, including those personnel performing or participating in invalidations.
  • Each country has regulatory requirements which must be adhered to, which can impact individual roles within the company.
  • Understanding of individual role in achieving company quality objectives and QMS compliance.
What You’re Bringing with You
  • Bachelor’s degree or currently enrolled in a bachelor’s program with a completed pacemaker school certification required.
  • If FTS is currently working toward a bachelor's, FTS must maintain full coursework during employment and maintain a 3.0 or greater GPA to remain eligible for employment
  • Experience with customer-facing relationships including extensive experience with both physicians and patients.
  • Experience with operating room procedures, clinic, and surgical center protocols.
  • Valid driver’s license.
  • Ability to consistently travel an estimated 75% required – Including Weekends. Travel may fluctuate up or down based on the weekly needs of the business 
  • Ability to effectively communicate with personnel outside the U.S. in the spoken and written English language.
  • Ability to manage and coordinate multiple assignments effectively.
  • Ability to lift implant bag of approximately 40 lbs 
  • Ability to walk long distances, navigate airports with luggage and negotiate staircases with implant bags.
Our Commitment to You
Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that’s enjoyable, thorough, and fair. That’s our way of inspiring the innovative brightest minds.
 
Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around a diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference.
 
Equal Opportunity Employer Statement:
Impulse Dynamics is an equal opportunity employer.
 
Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.
 
 
 
 
 
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