Lead Pilot Manufacturing Engineer — Wearable Robotics

Epia Neuro; Alameda (CA); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Competitive base salary with equity

100% healthcare coverage for you and 


100% healthcare coverage for you and你的

Generous vacation policy

Paid parental leave

Work from our Alameda waterfront офис

Job summary

Epia Neuro is seeking a Senior Manufacturing Engineer to design and operate our first in-house pilot assembly line for the wearable robotics device. You will secure equipment, set up workstations, and develop tooling and fixturing with the engineering team.

You will own manufacturing readiness for DVT and early clinical builds, ensuring units meet design and quality standards on schedule while translating prototypes into scalable processes and managing supplier relationships.

Qualifications

• 7+ years of manufacturing engineering experience within the medical device industry.
• Hands-on 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.
• 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.
• Bachelor's degree in Mechanical, Manufacturing, Industrial, or Biomedical Engineering, or equivalent hands-on experience.

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 DVT and early clinical builds, ensuring line meets design and quality requirements on schedule.
• Translate prototype processes into producible, repeatable manufacturing processes (design for manufacturability / design transfer).
• Manage supplier relationships, including quality issues, delivery performance, and cost/lead-time negotiations.
• Develop and maintain manufacturing documentation (work instructions, travelers, BOMs, equipment specs).
• Support IQ/OQ/PQ validation activities as production scales.
• Contribute to risk management activities for manufacturing processes.

Skills

Pilot line setup

Medical device manufacturing

Supplier management

Design transfer

DVT/EFS

Documentation

Quality systems

Early-stage medtech

Education

Bachelor's degree in engineering

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 Mechanical Engineer to build out our first in-house pilot manufacturing line for our wearable robotic exoskeleton, supporting the transition from prototype through design verification and early clinical production.

Reporting to the Robotics Manager, you’ll design and build the fixtures, tooling, test setups, workstations, and processes needed to assemble and test the exoskeleton reliably and repeatedly. You’ll work closely with the engineering team to translate evolving prototypes into practical, repeatable manufacturing processes.

This is a highly hands-on role for someone who can move between mechanical design and the manufacturing floor - designing what’s needed, building it, testing it, and iterating as the pilot line takes shape.

Location

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.

What You’ll Do

• Build and bring up our first in-house pilot assembly line, including equipment, workstations, tooling, and test setups.

• Translate engineering prototypes and assembly/test methods into repeatable manufacturing processes for DVT and early clinical builds.

• Adapt and productionize engineering fixtures and tooling for pilot manufacturing, developing additional manufacturing tooling as needed.

• Partner with R&D to resolve manufacturability, assembly, and testability issues as designs evolve.

• Own pilot manufacturing readiness, documentation, and supplier coordination to ensure units are built reliably and on schedule.

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

Qualifications

• 7+ years of mechanical and/or manufacturing engineering experience, with strong hands-on experience in mechanical design, CAD, fixtures, tooling, and assembly/test processes.

• Experience taking hardware from prototype into pilot or low-volume production, including establishing repeatable manufacturing processes.

• Experience working with complex electromechanical systems and partnering closely with R&D through DVT and early production builds.

• Demonstrated ability to build processes and solve problems hands-on in an early-stage or similarly ambiguous environment.

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

Preferred Qualifications

• Medical device experience, including Class II/III devices and ISO 13485/FDA-regulated environments.

• Experience with DFM, design transfer, manufacturing documentation, and process validation (IQ/OQ/PQ).

• Experience with wearable robotics, mechatronics, or similarly complex electromechanical products.

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.

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.

Benefits

• Full-time employees are eligible for the following benefits:

  • Competitive base salary with equity

  • 100% of healthcare coverage for you and your dependents

  • Generous vacation policy

  • Paid parental leave

  • Work from our beautiful waterfront office in Alameda, CA, with access to collaborative spaces and labs.