Senior Mechanical Engineer, Pilot Manufacturing

Epia Neuro; Alameda (CA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Competitive Base Salary

Equity

Healthcare Coverage for Employee and [

Dependents

Generous Vacation Policy

Paid Parental Leave

Waterfront Office and Collaborative Sp

Job summary

Epia Neuro is seeking an experienced Mechanical/Manufacturing Engineer to build the company’s first in-house pilot assembly line, including workstations, equipment, fixtures, tooling, and test setups. You will establish repeatable processes and documentation for design verification and early clinical builds.

You will collaborate with R&D to resolve production issues, support validation, and coordinate with suppliers, contributing to a smooth transfer from prototype to pilot production.

Qualifications

• 7+ years of mechanical and/or manufacturing engineering experience.
• Hands-on mechanical design and CAD skills; experience taking electromechanical hardware from prototype to pilot/low-volume production.
• Bachelor's degree in a relevant engineering field; medical-device, regulated-environment, DFM, IQ/OQ/PQ experience preferred.

Responsibilities

• Build and bring up the first in-house pilot assembly line with workstations, equipment, fixtures, and tooling.
• Develop repeatable manufacturing processes and documentation for design verification and early clinical builds.
• Partner with R&D to resolve production issues and support validation and supplier coordination.

Skills

Mechanical Design

CAD

Fixture Design

Tooling

Pilot Manufacturing

Assembly Processes

Test Processes

Electromechanical Systems

Design for Manufacturability

Design Transfer

Manufacturing Documentation

Process Validation

Supplier Coordination

Manufacturing Risk Management

Medical Device Manufacturing

Problem Solving

Education

Bachelor's degree in a relevant engineering field

Tools

CAD software

Job description

Build and bring up the company’s first in-house pilot assembly line, including workstations, equipment, fixtures, tooling, and test setups. Establish repeatable manufacturing processes and documentation for design verification and early clinical builds, partnering with R&D to resolve production issues and support validation and supplier coordination.

Requirements

Requires 7+ years of mechanical and/or manufacturing engineering experience, strong hands-on mechanical design and CAD skills, and experience taking complex electromechanical hardware from prototype into pilot or low-volume production. A bachelor’s degree in a relevant engineering field or equivalent practical experience is required; medical-device, regulated-environment, DFM, design-transfer, and IQ/OQ/PQ experience are preferred.

Key Skills

Mechanical Design, CAD, Fixture Design, Tooling, Pilot Manufacturing, Assembly Processes, Test Processes, Electromechanical Systems, Design for Manufacturability, Design Transfer, Manufacturing Documentation, Process Validation, Supplier Coordination, Manufacturing Risk Management, Medical Device Manufacturing, Problem Solving

Benefits

• Competitive Base Salary
• Equity
• Healthcare Coverage for Employee and Dependents
• Generous Vacation Policy
• Paid Parental Leave
• Waterfront Office and Collaborative Spaces