Lead Manufacturing Engineer - design, prototyping, mfg/process development - medical device

InnoTECH Staffing has partnered with an exciting medical device start-up in the Boston area and is looking to hire a fulltime permanent Lead / Senior Manufacturing Engineer.

This will require being onsite in the Boston office and occasional travel to the CMO.

The company received FDA Breakthrough Device Designation and preparing for first-in-human studies.

This will be the first manufacturing person the company has hired.

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.

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

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
• Min of 5+ years of medtech manufacturing experience
• Hands-on experience with any of the following a huge plus:
  • 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

Competitive Base salary, Equity, full medical, dental, vision, generous PTO and company holiday time off, and paid parental leave - as well as the opportunity to build something meaningful from the ground up!!!