Senior Manufacturing Engineering

Epia Neuro is a neural technology company developing intent-driven systems designed to restore function and independence for people living with neurological conditions. Its platform integrates implantable neural interfaces, adaptive algorithms, and assistive devices to translate neural intent into real-world action. We’re looking for a Senior Manufacturing Engineer to build and own our first in-house pilot assembly line for our wearable robotics device, taking it from prototype builds through design verification and clinical builds.
As a Senior Manufacturing Engineer, you will report to the Robotics Manager and be responsible for building out the manufacturing processes, tooling, supplier relationships, and documentation needed to build the wearable robotics device in house.
This role is based out of the San Francisco Bay Area, and expected to work on site from our Alameda Headquarters 4-5x a week.
We care for others. We prioritize safety both for patients and one another.
Design, build, and bring up an in‑house pilot assembly line for the wearable robotics device (end effector and actuation hardware), including procuring equipment, setting up workstations, and developing tooling and fixturing alongside the engineering team.
Own manufacturing readiness for Design Verification Testing (DVT) and early clinical builds, ensuring the line reliably produces units that meet design and quality requirements on schedule.
Partner with R&D and design engineering to translate prototype and engineering‑build processes into producible, repeatable manufacturing processes (design for manufacturability / design transfer).
Manage ongoing supplier relationships, including quality issues, delivery performance, and cost/lead‑time negotiations.
Develop and maintain manufacturing documentation, including work instructions, process travelers, bills of materials, and equipment/tooling specifications.
Support process validation activities (IQ/OQ/PQ) as the line matures toward higher‑volume production.
Contribute to risk management activities for manufacturing processes.
7+ years of manufacturing engineering experience within the medical device industry.
Direct, hands‑on experience setting up a pilot or low‑volume production line from scratch, including layout, tooling/fixture development, and process definition.
Experience manufacturing Class II or Class III medical devices.
Experience developing manufacturing documentation (work instructions, travelers, BOMs, DHR/DMR‑related records) within a medical device quality system.
Bachelor's degree in Mechanical, Manufacturing, Industrial, or Biomedical Engineering, or equivalent hands‑on experience.
Experience with ISO 13485 and/or FDA 21 CFR 820 quality management systems.
Experience with design‑for‑manufacturability (DFM) and formal design transfer from R&D to production.
Experience with electromechanical assemblies (mechanical, electrical, and/or soft‑goods integration.
Experience at an early‑stage medtech or wearable robotics company.
Ability to stand and move throughout a lab/production floor for extended periods; frequent use of hands for fine‑motor assembly tasks and hand tools; visual acuity sufficient for detailed assembly and inspection work, including under magnification when required.
Full‑time employees are eligible for the following benefits listed below.
Competitive base salary with equity
100% of healthcare coverage for you and your dependents
Generous vacation policy
Work from our beautiful waterfront office in Alameda, CA, with access to collaborative spaces and labs.

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