Senior or Principal Manufacturing Engineer - medical device implant
About The Position
InnoTECH Staffing is seeking a Manufacturing Engineer with experience in medical device implants for a company in the Greater Boston area. This is a hands-on role requiring onsite work in Boston. The engineer will partner with the Senior Mechanical Engineer on the design, prototyping, and manufacturing-process development of a depth lead component. Responsibilities include owning manufacturing process development and qualification, leading root-cause investigations of device failures, and significant bench work at the company and with CM partners. The company is open to candidates at Senior, Staff, or Principal levels, with the title and offer calibrated based on experience and scope. The core work remains consistent across levels, with differences in ownership breadth, technical depth, and influence.
Requirements
- B.S. or M.S. in Mechanical or Materials Engineering (or related discipline).
- Class III active implantable device experience: Direct hands-on experience with at least one Class III active implantable device (neural lead, IPG, neurostimulator, cardiac rhythm management device, cochlear implant, or comparable) from prototype through clinical or commercial builds.
- Manufacturing process experience: Demonstrated experience with at least two of the following manufacturing processes applied to miniature implantable assemblies: insert or over-molding of polymers around fine-gauge wire and metal contacts; multilumen polymer extrusion handling; centerless grinding of finished assemblies; laser welding of fine-gauge wire to ring or lug structures; polyurethane reflow.
- Working familiarity with FDA Design Controls (21 CFR 820.30) and ISO 13485.
- US Citizen or Permanent Resident.
- Must be able to work onsite in Boston.
Nice To Haves
- Direct experience with neural leads or DBS leads.
- Experience with micro injection molding and production of micro-scale device assemblies.
- Cross-sectioning, metallographic, or micro-CT / X-ray failure analysis of implantable assemblies.
- Materials selection for implantable devices (ISO 10993).
- Prior startup or small-company medtech experience.
Responsibilities
- Lead process engineering and production support at contract manufacturing partners, including embedded on-site work during critical builds.
- Develop, document, and qualify manufacturing processes for HFE, GLP, design verification, clinical builds, and commercialization, with controls and validation rigor commensurate with each phase.
- Lead structured root-cause investigations on lead failures observed in builds, bench testing, accelerated aging, and in vivo studies, including cross-sectioning, dissection, and metallographic failure analysis on multi-channel leads.
- Author process procedures, change orders, equipment specifications, pFMEAs, and validation plans (IQ/OQ/PQ).
- Collaborate with R&D and suppliers to improve product robustness and manufacturability.
- Establish the Manufacturing Quality Plan for the depth lead.
Benefits
- Base salary range: $105,000–$205,000, commensurate with level and experience.
- Stock options, with grant size scaled to level.
- Comprehensive medical, dental, and vision insurance.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
