$130,000–$150,000 Per Year
3D Modeling, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Cardiology, Congestive Heart Failure, Experiment Design, Failure Analysis, Feasibility Analysis, Implants, Maintain Compliance, Medical Equipment, Medical Products, Patient Care, Process Development, Process Engineering, Process Failure Mode and Effects Analysis (PFMEA), Product Development, Product Lifecycle, Regulatory Compliance, Regulatory Submissions, Reliability Engineering, Risk Analysis, Risk Management, Standards Development, Systems/Internals Programming, Team Player, Technical Writing, Technical/Engineering Design, Test Plan/Schedule, Testing, Validation Testing, Verification Plans
This role is ideal for an experienced engineer who thrives in a fast‑growing, innovation‑driven medical device environment. You will play a critical role in the development, optimization, and lifecycle management of implantable medical devices designed to improve outcomes for patients with chronic heart failure.
Client Details
My client is driven by a mission rooted in innovation, transparency, and patient benefit, the company emphasizes excellence in design, adherence to global regulatory standards, and the development of a collaborative, talent‑focused workplace. With continued investment, substantial venture backing, and ongoing expansion of its technology platform, the organization remains at the forefront of advancing next‑generation treatment solutions for chronic heart failure
Description
The key responsibilities of the Senior Process Development Engineer are:
- Lead the design, development, and refinement of next‑generation implantable pulse generator systems and external programmer technologies.
- Develop and execute test plans, verification/validation studies, and design feasibility assessments for implantable cardiac devices.
- Engage with suppliers and engineering partners to ensure adherence to technical performance targets, manufacturability, and reliability standards.
- Utilize design-for-manufacture, risk management, and reliability engineering methodologies to drive product robustness and long‑term performance.
- Generate high‑quality technical documentation for design history files (DHF), risk analyses, FMEAs, and regulatory submissions
If interested, please apply using the link below. Qualified applicants will be contacted 24-48 hours upon submittal.
Profile
The successful Senior Process Development Engineer will have:
- Bachelor's degree in Engineering, advanced degree preferred.
- 5+ years of experience in medical device product development
- Skilled in PFMEA, Failure Analysis, and Design of experiments
- Experience at all levels of the medical device product lifecycle
- Proficiency with statistical tools, CAD, 3D Modeling
Job Offer
My client can offer the following:
- Full Coverage Medical Benefits - Employee + family contribution is 100%
- Paid Vacation, floating holidays, and sick time.
- Paid Holidays
- 401k Match (up to 6%)
- Annual bonus eligibility
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.