Senior Manufacturing Engineer - neurostimulation / active implant / miniature implantable assemblies

Job Description

Job Description

InnoTECH Staffing is partnering with a cutting-edge neurostimulation startup 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.

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.

• 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

You thrive in fast-paced, build-heavy environments and love solving complex process problems. You’re as comfortable rolling up your sleeves at the bench as you are presenting technical findings to executive leadership.

You care deeply about getting it right—not just because it’s good engineering, but because patients are waiting.

• B.S. or M.S. in Mechanical, Materials, or related engineering field
• 2–5+ years of medtech manufacturing experience
• Hands-on experience with miniature implantable assemblies , including at least two 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

• 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

• Full medical, dental, and vision coverage
• Generous PTO + company holidays
• Paid parental leave
• The opportunity to build something meaningful from the ground up

If you’re looking for a role where you can own, build, troubleshoot, and truly impact a life-changing medical device , this is it.