Manufacturing Engineer - Implantable Leads (Senior, Staff, Principal)

Manufacturing Engineer - Implantable Leads (Senior, Staff, Principal) at Nia Therapeutics Manufacturing Engineer - Implantable Leads (Senior, Staff, Principal) at Nia Therapeutics in BROOKLINE, Massachusetts Posted in about 24 hours ago.

Type:

full-time

Job 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 component.

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. We are open to candidates at three levels: Senior, Staff, or Principal; and will calibrate the title and offer based on the experience and scope you bring. The core work is the same at every level; what differs is the breadth of ownership, technical depth, and influence we expect you to exercise. 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. 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). 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.

Regulatory familiarity:

Working familiarity with FDA Design Controls (21 CFR 820.30) and

ISO 13485.

Preferred Qualifications 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. Level Expectations We use the following framework to calibrate level during the interview process. Candidates do not need to self-select a level when applying; we will discuss fit during the hiring conversation.

Senior Manufacturing Engineer Experience:

B.S. + 3-7

years, or

M.S. + 2-6

years of relevant medtech manufacturing experience.

Scope of ownership:

Owns end-to-end process for a feature or sub-assembly; drives qualification independently.

Technical depth:

Demonstrated proficiency in two or more relevant processes; runs structured root-cause investigations.

Influence and leadership:

Mentors junior engineers informally; leads small cross-functional efforts.

Decision-making:

Makes day-to-day process decisions independently; escalates novel issues.

Staff Manufacturing Engineer Experience:

B.S. + 8-11

years, or

M.S. + 7-10

years of relevant medtech manufacturing experience.

Scope of ownership:

Owns the manufacturing process strategy for the depth lead across builds and contract manufacturing partners.

Technical depth:

Recognized expert in implantable lead manufacturing; resolves novel failure modes others cannot.

Influence and leadership:

Mentors engineers across levels; influences program-level decisions; drives CMO relationships.

Decision-making:

Makes process and qualification decisions that impact program timelines and regulatory submissions.

Principal Manufacturing Engineer Experience:

B.S. + 12+ years, or M.S. + 11+ years of relevant medtech manufacturing experience.

Scope of ownership:

Sets the long-horizon process and supply strategy for implantable leads across the SNS platform.

Technical depth:

Defines the state of the art for Nia in lead manufacturing engineering; recognized externally in the field.

Influence and leadership:

Shapes technical direction across teams; trusted partner to the CTO on build strategy and risk.

Decision-making:

Makes architectural decisions on lead manufacturability that shape the product roadmap. Location Full-time, on-site at our Allston, MA office. Domestic travel required. Must be eligible to work in the US. Compensation and Benefits Base salary range: $105,000-$205,000, commensurate with level and experience. Specific level bands within this range will be discussed during the interview process. Stock options, with grant size scaled to level. Comprehensive medical, dental, and vision insurance.