Senior Manufacturing Engineer, MedTech Pilot Line

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

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