Senior Manufacturing Engineer - NPI - medical device
About The Position
InnoTECH Staffing is partnering with a cutting-edge medical device start-up in Boston that is developing next-generation implantable technology designed to make a real difference for patients. This is a rare opportunity to join early, work side-by-side with leadership, and directly shape a Class III active implantable device from prototype through commercialization. The role is a Senior Manufacturing Engineer. Must be able to work onsite in Boston and be able to travel to CM partners. Must be a US Citizen or GreenCard holder - there is no sponsorship. This isn’t a maintenance manufacturing job. You’ll be at the center of innovation—owning how a complex, miniaturized implantable lead is actually built, scaled, and perfected. You’ll work hands-on at the bench, in close collaboration with R&D, and directly with the CTO to bring a breakthrough device to life. Reporting to the CTO, you’ll partner closely with the senior mechanical engineer to design, prototype, and industrialize a highly complex depth lead device. You’ll own manufacturing process development end-to-end—and when something breaks, you’ll be the one figuring out why and making it better. This is a deeply hands-on, high-ownership role where your work directly impacts patient outcomes.
Requirements
- B.S. or M.S. in Mechanical, Materials, or related engineering field
- 5+ years of medtech manufacturing experience
- Hands-on experience with at least 2 of the following: Polymer overmolding / insert molding around fine wires, Multi-lumen extrusion handling, Centerless grinding, Laser welding of fine-gauge components, Polyurethane reflow
- Working knowledge of FDA Design Controls (21 CFR 820.30) and ISO 13485
Nice To Haves
- Experience with Class III implantable devices (neuro, cardiac, cochlear, etc.)
- Micro-scale manufacturing or micro-injection molding
- Advanced failure analysis (cross-sectioning, metallography, micro-CT/X-ray)
- Knowledge of implantable materials and ISO 10993
- Startup or early-stage company experience
Responsibilities
- Own manufacturing process development and qualification from early builds through commercialization
- Embed with contract manufacturers during critical builds to dial in processes in real time
- Lead root-cause investigations on device failures (bench, aging, in vivo)—including cross-sectioning and failure analysis
- Design and execute DOEs to characterize and optimize new processes
- Develop and author pFMEAs, validation protocols (IQ/OQ/PQ), process specs, and change orders
- Collaborate cross-functionally with R&D and suppliers to improve manufacturability and robustness
- Establish the Manufacturing Quality Plan for a next-gen implantable lead
Benefits
- Full medical, dental, and vision coverage
- Generous PTO + company holidays
- Paid parental leave
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What This Job Offers
Job Type
Full-time
Career Level
Senior
