• Inventory, Receiving, and Storage
• Receive, inspect, and process incoming goods and materials.Ensure proper storage conditions and accurate labeling of inventory.
• Maintain real-time inventory records and perform cycle counts and reconciliations.
• Manage inventory accuracy, adjustments, and reporting within Business Central and Salesforce.
• Process returns and ensure proper documentation and disposition of goods.
• Shipping & Logistics Operations
• Coordinate domestic and international shipments, including scheduling carriers and freight forwarders.
• Prepare and verify shipping documentation (commercial invoices, packing lists, export documents, etc.).
• Track shipments from dispatch through final delivery.
• Obtain and maintain proof of delivery (POD) for all shipments.
• Ensure cost-effective and timely transportation methods.
• Trade Compliance & Customs (Regulatory Requirement Heavy)
• Classify goods using correct Harmonized System (HS) codes in accordance with international trade regulations.
• Ensure accurate commodity descriptions and declarations on all import/export documentation.
• Support compliance with U.S. Customs and Border Protection (CBP) regulations and applicable international trade laws.
• Review customs entries for accuracy and identify discrepancies or erroneous broker filings.
• Initiate and manage duty/tax drawback or refund claims related to incorrect customs entries.
• Coordinate with customs brokers, freight forwarders, and government agencies as required.
• Maintain audit-ready records for all import/export transactions.
• Procurement & Issue Resolution
• Support procurement activities related to logistics and shipping materials/services.
• Investigate and resolve shipment, documentation, and customs-related issues.
• Collaborate with internal departments to ensure smooth material flow.

• 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 improper performance of specific job function, including those personnel performing or participating in validations.
• Knowledge of country 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.
• Working knowledge of international trade compliance regulations, including CBP requirements.
• Understanding of HS classification systems and commodity declaration principles.
• Familiarity with import/export documentation requirements and customs brokerage processes.
• Knowledge of inventory control principles and warehouse management practices.
• Understanding of domestic and international shipping methods, carriers, and logistics networks.
• Proficiency in ERP systems and shipment tracking tools.
• Strong attention to detail, particularly in documentation accuracy and data integrity.
• Ability to analyze discrepancies and support financial recovery of duties/taxes when applicable.
• Strong organizational, communication, and cross-functional coordination skills.

• Develop, implement and validate manufacturing process for implantable electronic medical devices

  o Equipment specification, procurement, installation and validation

  o Manufacturing fixture/tooling specification, design and procurement

  o Manual and semiautomatic assembly

  o Laser welding, resistance welding, manual soldering

  o Surface treatment, cleaning processes

  o Molding

  o DOE, range finding

  o Cross sections sample analysis

  o Process optimization

  • Provide technical leadership and mentorship to the engineering team

  • Collaborate with cross-functional teams including Supply Chain, Quality, and R&D on product requirements

  • Maintain strong relationships with consultants and suppliers

  • Maintain thorough documentation of engineering activities

  • Establish and adjust work procedures to meet standard policies related to quality.

  • Implement processes and workflows that are effective and efficient.

  • Track KPIs for team’s performance

• Bachelor's degree in engineering, mechanical is preferred.
• Advanced degree preferred.

• • Minimum of 2 years of experience in developing manufacturing processes in the medical device industry.

  • Experience with implantable pulse generator assembly preferred

  • Risk analysis – PFMEA

  • Failure analysis

  • Design of experiments

  • Strong knowledge of FDA regulations, ISO standards, and other relevant medical device regulations.

  • Excellent problem-solving skills and attention to detail.

  • Strong communication and interpersonal skills.

  • Ability to work effectively in a fast-paced, collaborative environment.

  • Proficient experience at all levels of the medical device product lifecycle.

  • Strong working knowledge of Microsoft Office

  • Proficiency with statistical tools, CAD, 3D modeling, Laser/RSW is preferred

• Write or contribute to the preparation of clinical protocols, amendments, informed consent forms, case report forms, monitoring plans, data management plans, and any other clinical research-related documents.
• Proactively coordinate, manage and oversee the various project-level operational aspects of the CTT including management of trial timeline, budget, resources, and vendors.
• Provide regular updates on trial progress to clinical leadership with respect to vendor selection, project plans, trial budget and timeline management, and risk mitigation.
• Lead study startup processes, including but not limited to conduct of the clinical trial Investigator meeting together with clinical and medical leadership, site selection, and finalization of site clinical trial site agreements and budgets.
• Ensure effective project plans are in place and operational and work proactively with the CTT to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines, and regulatory requirements.
• Ensure potential study risks are escalated to the attention of clinical leadership when appropriate.
• Lead the CTT working group and vendor status update meetings.
• Ensure tracking, follow-up, and resolution of site monitoring issues in a timely manner.
• Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution, and quality control across the clinical team.
• Support all activities related to clinical trial oversight committees (Steering Committee, DSMB, Clinical Events Committee).
• Assist with CRA and third-party vendor training on protocols and practices.
• Develop and maintain good working relationships with investigators and study staff.
• Contribute to writing annual progress reports and final reports to regulators, as required.

• Bachelor’s degree or higher, in a scientific, clinical, or related field
• For Associate CTM: Minimum of 2 years of progressive experience in clinical operations, clinical trial management, or project management within the pharmaceutical, biotechnology, medical device, or contract research organization (CRO) industries. Experience supporting multicenter clinical studies preferred
• For CTM: Minimum of 4 years of progressive experience in clinical operations, clinical trial management, or project management within the pharmaceutical, biotechnology, medical device, or contract research organization CRO) industries. Demonstrated experience independently managing clinical studies or major study workstreams.
• Hands-on-experience managing or supporting Investigational Device Exemption (IDE) clinical trials is required.
• Working knowledge of FDA regulations, ICH-GCP, and clinical trial best practices.
• Strong project management, organizational, and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Excellent written, verbal, and interpersonal communication skills.
• Proficiency with Microsoft Office applications and clinical trial management systems.
• Preferred: Prior experience in heart failure and/or cardiac rhythm management clinical studies is strongly preferred. Experience managing CROs and external vendors.

• Conduct all assigned tasks under the direction of the Director of Engineering (or higher).
• Execute electrical test procedures and document results. This is applicable to devices at any point in the product lifecycle, including prototypes for development use, pilot production of saleable product, or returned devices under investigation.
• Develop and/or update electrical test procedures, corresponding forms, and reports.
• Design and prototype electrical test fixtures.
• Assist product development engineers in design, verification, and validation of automated electrical test systems.
• Execute and/or manage deployment and maintenance of automated electrical test systems.
• Assist product development engineers in design and prototyping of electronic devices (may include schematic capture, PCB layout, component specification and procurement, assembly and board bring-up)
• Write clear and detailed technical reports and procedures in English.
• Coordinate technical aspects of assigned tasks with other group engineers and technical staff at electronic assembly vendors.
• Procure, operate, and maintain engineering lab equipment.
• Ensure assigned tasks are completed in compliance with departmental standard operating procedures and corporate quality policies.
• Perform other tasks in support of the operation of the Product Development department as assigned.

• 2+ years of experience in a hands-on electronics-related work environment (substantial academic research may be considered as equivalent)
• Bachelor’s or graduate degree in Electrical and Computer Engineering, or equivalent work experience
• Ability to execute electronic test procedures
• Ability to use electronic test equipment, including Oscilloscopes, meters, power supplies, and function generators
• Ability to read and understand schematics.
• Ability to solder and assemble electronic prototypes • Ability to function well in a self-driven, start-up like environment and balance multiple assignments
• Strong ability to communicate in English, including writing technical documentation

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®, which is delivered by the company’s Optimizer® systems. 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.; Beijing, China and Montevideo, Uruguay.

There are ≈ 64 million patients struggling with heart failure worldwide. When heart failure patients continue to decline despite being on optimum pharmaceutical therapy, they lose hope. The only options down the road (LVAD or heart transplant) are extremely invasive and rarely used. 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 are qualified for CCM® therapy. The PROSPECT campaign is a direct to patient advertising and awareness campaign designed to help CCM® eligible patients help themselves to this life-changing therapy. This campaign requires an orchestrated sequence of patient identification and nurture that is managed principally by Impulse Dynamics’ NEXUS call center. Nexus connects CCM® indicated patients to providers by activating and enabling a network of the best medical device and therapy awareness representatives in the world to educate the cardiology community.

Patient Success Associate – (FTE)

Impulse Dynamics has recently built out a Direct-to-Patient marketing function and is receiving a high volume of inbound inquiries from potential patients. To help field this demand, create a world-class patient experience, and ensure patients’ needs are being met, we are building our internal Patient Success capabilities and looking to hire our first Patient Success Associate to help drive this impactful program. This role will combine technical and business acumen while connecting with patients and internal teammates to drive CCM awareness across the U.S. This position is contract-to-hire with the intent to move to full-time employment in early 2024, or sooner.

As a Patient Success Associate, you will support qualified PROSPECT patients through their CCM® journey while aiming for maximum efficiency and effectiveness. You will also ensure that process and technology is utilized to a maximum and that your patient “book of business” is organized and professionally managed.

An excellent Patient Success Associate must be an organized, reliable, and a results-driven professional. They must possess a practical mind to solve problems on the spot, partnered with an ability to see the big picture for individual growth and development opportunities. And they must execute reliably on their own volition.

As the Patient Success Associate, you must have excellent customer service and communication skills. Reporting to the Sr. Patient Success Operations Manager, the Patient Success Associate will be a partner in supporting the daily patient outreach function for all interested PROSPECT patients, and work with our field teams to help ensure that CCM® implant goals are met or exceeded.

A best-in-class patient success function will be critical to our ability to deliver on Impulse Dynamics’ mission.

Please apply if:

· You are passionate about improving the lives of patients through the provision of novel therapies in the heart failure community.

· You love working in and with high performing teams.

· You are driven, influential, and energetic.

· You will hit the ground running as a high-performing Patient Success Associate and are excited to partner in improving our operational function.

· You thrive in a changing environment and find yourself consistently solutioning through establishing best practices.

Essential Functions The Patient Success Associate will:

· Ensure the achievement of all established KPIs.

· Meet or exceed pre-established monthly enrollment goals.

· Build and establish best practices regarding the handling of patient objections and concerns.

· Be responsible for special projects and other duties as assigned by the Sr. Patient Success Operations Manager.

· Nimbly address inquiries and objections.

Minimum qualifications:

· 2+ years of experience in a patient-centric environment.

· Bachelor’s degree from an accredited institution.

· Experience with Salesforce, Tableau, and 8x8 or similar telephony systems.

· Previous experience in customer service and/or patient experience in a telephonic environment.

· Previous experience working remotely or with autonomy.

Preferred qualifications:

· Excellent written communication skills to ensure information continuity with field teammates.

· Highly collaborative with field teammates to ensure exceptional patient experience, and with the Patient Success leadership in your work to build the Patient Success team.

· Growth mindset towards your professional development at Impulse Dynamics.

· Growth mindset towards leading within the Patient Success function.

· Embrace change and constantly stretch comfort zone in the spirit of continuous improvement.

· Identify and collaborate to solve complex problems while driving Patient Success continuous improvement.

· Passionate about Impulse Dynamics’ vision to improve the lives of heart failure patients using cardiac contractility modulation CCM®.

· Experience training others, particularly for engaging in conversation with the intent to move patients through a funnel or similar functions.

· Nursing experience, specifically with the Heart Failure population.

· Fluency in another language (ideally Latin-American Spanish).

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.

• Assist with monthly financial close processes.

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

• 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

• 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.