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Process Development Engineer

Process Development 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.
 
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.  

The primary responsibility of the Process Development Engineer will be to develop, implement and validate manufacturing processes for electronic implantable medical devices. Will also provide oversight and guidance to technicians and engineers developing manufacturing processes.

How You’ll Add Value

  • 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

What You’re Bringing with You
  • 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

 
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.
 

Compensation & Benefits

Annual Base Salary Range: $ 85,000 - $ 105,000

  • Full Coverage Medical Benefits – Employee + family contribution is 100% covered by Impulse Dynamics.
  • Paid Vacation, floating holidays, and sick time.
  • Paid Holidays
  • 401k Match (up to 6%)
  • Annual bonus eligibility


Unless specifically indicated communicated otherwise in writing, all employees are “at-will” employees.  The Company reserves the right to modify the aforementioned terms with appropriate notice and under no circumstance do the above described compensation and benefits constitute a promise to continue them for the duration of an employee’s employment.


 

ID - 8a7887a89efb878a019f0b3ae98268c3

Process Development Engineer

Location: United States Marlton NJ
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Process Development 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.
 
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.  

The primary responsibility of the Process Development Engineer will be to develop, implement and validate manufacturing processes for electronic implantable medical devices. Will also provide oversight and guidance to technicians and engineers developing manufacturing processes.

How You’ll Add Value

  • 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

What You’re Bringing with You
  • 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

 
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.
 

Compensation & Benefits

Annual Base Salary Range: $ 85,000 - $ 105,000

  • Full Coverage Medical Benefits – Employee + family contribution is 100% covered by Impulse Dynamics.
  • Paid Vacation, floating holidays, and sick time.
  • Paid Holidays
  • 401k Match (up to 6%)
  • Annual bonus eligibility


Unless specifically indicated communicated otherwise in writing, all employees are “at-will” employees.  The Company reserves the right to modify the aforementioned terms with appropriate notice and under no circumstance do the above described compensation and benefits constitute a promise to continue them for the duration of an employee’s employment.


 

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