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

InnoTech Staffing•Boston, MA

1d•Onsite

About The Position

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.

Requirements

B.S. or M.S. in Mechanical, Materials, or related engineering field
Min of 5+ years of medtech manufacturing experience
Working knowledge of FDA Design Controls (21 CFR 820.30) and ISO 13485

Nice To Haves

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
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