Commercialization

InnoTech Staffing•Boston, MA

3d•Onsite

About The Position

InnoTECH Staffing is looking to hire a fulltime permanent Senior Manufacturing Engineer for an exciting and growing Brain-Computer Interface start-up in the Boston area. The ideal candidate will have proven experience taking complex medical device products from development to commercialization. This person will work side-by-side with the Sr ME on the design, prototyping, and manufacturing-process development of the device. This is a hands-on role: you will own manufacturing process development and qualification, lead structured root-cause investigations on device failures, and spend significant time at the bench at company and at the CMO. We are seeking someone who is energized by bench work and process problems. Must be equally comfortable working onsite for a week at the contract manufacturer to dial in a build, designing and running a structured DOE to characterize a new process, and presenting a pFMEA to the CTO.

Requirements

B.S. or M.S. in Mechanical or Materials Engineering (or related discipline).
Several years of relevant medtech manufacturing experience.
Demonstrated experience with process development and optimization.
Working knowledge of FDA Design Controls (21 CFR 820.30) and ISO 13485.
Must be authorized to work in the US (visa sponsorship is not available for this role).

Nice To Haves

Experience with Class III active implantable devices (neural lead, IPG, neurostimulator, cardiac rhythm management device, cochlear implant, or comparable).
Experience with the following: (a) insert or over-molding of polymers; (b) small scale assemblies; (c) laser systems; (d) polymer reflow.
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.
Review and 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.