Lead Pilot Manufacturing Engineer — Wearable Robotics

Epia Neuro; Alameda, Northern (CA, KY); 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

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.