Staff Manufacturing Engineer

Epia Neuro; Alameda (CA); On-site; USD 130,000 - 180,000; Full time

Job summary

Epia Neuro is seeking a Staff Manufacturing Engineer to design and stand up the first in-house pilot assembly line for its wearable robotics device. The role involves end-to-end development from prototype builds through design verification and early clinical builds, with responsibility for equipment, tooling, and process transfer.

You will collaborate with R&D and design engineering to convert prototype processes into scalable manufacturing, while ensuring quality and compliance for medical

Qualifications

• Bachelor’s degree in mechanical/manufacturing/industrial/biomedical engineering, or equivalent hands-on experience.
• 7+ years of manufacturing engineering experience in the medical device industry.
• Experience setting up a pilot or low-volume production line from scratch.
• Experience manufacturing Class II or Class III medical devices.
• Experience developing manufacturing documentation within a medical device quality system.

Responsibilities

• Design, build, and bring up an in-house pilot assembly line for the wearable robotics device, including equipment procurement and tooling development.
• Own manufacturing readiness for Design Verification Testing (DVT) and early clinical builds.
• Translate prototype processes into producible, repeatable manufacturing processes (DFM/DFT).
• Manage supplier relationships and qualify vendors for components and materials.
• Supervise build technicians and develop manufacturing documentation (work instructions, travelers, BOMs, DHR/DMR records).

Skills

Pilot line setup

Documentation

Supplier management

DVT/EFS knowledge

Education

Bachelor’s degree in Mechanical/Manufacturing/Industrial/Biomedical Engineering or equivalent hands-on

Tools

Process tooling/fixturing development

Quality systems awareness

Job description

About Us

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. The company’s initial focus is stroke-related motor impairment, with expansion in cognitive decline and other neurological disorders, focusing on long-term solutions for the growing aging population.

The Role

We’re looking for a Staff 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 Staff Manufacturing Engineer, you will report to the Robotics Manager and be responsible for standing up the manufacturing processes, tooling, supplier relationships, and documentation needed to build the wearable robotics device in house.

Location

This role is based out of the San Francisco Bay Area, and expected to work on site from our Alameda Headquarters 4-5 a week.

How We Work

• We are intentional. We prioritize and are thoughtful about how we use others’ time.

• We care for others. We prioritize safety both for patients and one another.

• We own outcomes, not just tasks. Our work demands the highest standards because it impacts real patients and real lives.

• Humility is a strength. We are honest about what we know and what we don’t know. Getting it right matters more than being right.

What You’ll Do

• 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).

• Partner with Quality to identify, evaluate, and qualify suppliers and vendors for components, subassemblies, and materials used in the glove and control unit.

• Manage ongoing supplier relationships, including quality issues, delivery performance, and cost/lead-time negotiations.

• Manage build technicians on the line, including setting priorities, scheduling, and day-to-day supervision of builds.

• Develop and maintain manufacturing documentation, including work instructions, process travelers, bills of materials, and equipment/tooling specifications.

• Support Device History Record (DHR) and Device Master Record (DMR) documentation in alignment with design controls.

• Ensure manufacturing processes and documentation comply with the quality management system (ISO 13485 and/or FDA 21 CFR 820, as applicable).

• Support process validation activities (IQ/OQ/PQ) as the line matures toward higher-volume production.

• Contribute to risk management activities for manufacturing processes.

Qualifications

• Bachelor’s degree in Mechanical, Manufacturing, Industrial, or Biomedical Engineering, or equivalent hands‑on experience.

• 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.

• Experience engaging with, qualifying, and managing suppliers/vendors for components or subassemblies.

• Experience supporting early-stage build phases such as DVT, EFS, or first-article/pilot builds.

• Comfortable operating in a small-company/startup environment with limited existing infrastructure — builds process rather than just following it.

Preferred Qualifications

• 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 with process validation (IQ/OQ/PQ).

• Experience at an early-stage medtech or wearable robotics company.

Physical Requirements

• 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; occasional lifting/carrying of up to 25 lbs; visual acuity sufficient for detailed assembly and inspection work, including under magnification when required.

Benefits

• Full-time employees are eligible for the following benefits listed below.