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Senior Manufacturing Engineer: Implantable Leads
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Nia Therapeutics
Milton, MA (In Person)
Full-Time
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Job Description
Senior Manufacturing Engineer:
Implantable Leads atNia Therapeutics Senior Manufacturing Engineer:
Implantable Leads at Nia Therapeutics in Milton Village, Massachusetts Posted in about 20 hours ago.Type:
full-timeJob Description:
About Nia Therapeutics Memory loss is one of the largest unmet needs in medicine. More than 27 million Americans live with memory loss caused by traumatic brain injury, Alzheimer's disease, and aging. For these patients, no therapy - pharmacological or device - has been shown to restore the memory function they have lost. Nia Therapeutics is changing that. Our Smart Neurostimulation System (SNS) is the first AI-guided brain stimulation platform designed to restore memory, built on three decades of human neuroscience and DARPA-funded clinical research. In March 2026 we received FDA Breakthrough Device Designation for the treatment of memory loss following traumatic brain injury and are preparing for our first-in-human studies. A key component of the system is an implantable multi-channel lead that records and stimulates the human brain. The Role Reporting to the Chief Technology Officer, the person in this position will partner with our Senior Mechanical Engineer on the design, prototyping, and manufacturing-process development of our depth lead 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 Nia and at our contract manufacturing partners. About You You are energized by bench work and process problems. You are equally comfortable embedding for a week at a 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. You care about getting the device right because patients are waiting on it. What You'll Do 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.Required Qualifications Education:
B.S. or M.S. in Mechanical or Materials Engineering (or related discipline).Experience:
B.S. + 3
years (orM.S. + 2
years) of relevant medtech manufacturing experience.Process experience:
Demonstrated experience with at least two of the following, applied to miniature implantable assemblies: (a) Insert or over-molding of polymers around fine-gauge wire and metal contacts; (b) Multi-lumen polymer extrusion handling; (c) Centerless grinding of finished assemblies; (d) Laser welding of fine-gauge wire to ring or lug structures; (e) Polyurethane reflow Regulatory familiarity:Working knowledge of FDA Design Controls (21 CFR 820.30) and