Senior/Staff Manufacturing Engineer

Senior / Staff Manufacturing Engineer | San Diego, CA (100% on-site)

Summary

A venture-backed medical device startup in clinical studies is looking for a hands-on Manufacturing Engineer to own its in-house pilot line as it scales toward larger trials and commercial launch. This role is for a mechanical problem-solver. When a yield issue or an awkward assembly step slows the line, you'll sit with the operators, find the root cause, and design and build the fixture or tool that fixes it.

You'll also run the pilot line day to day with two capable operators, and set up the systems a growing manufacturing operation needs. Over the next 1–2 years, as the company builds a full operations team, line management will hand off and the role will shift toward scale-up and automation.

San Diego, CA | Onsite

$130K–$160K base + bonus & equity

Responsibilities

• Invent, design, and build custom fixtures, jigs, and tooling that improve yield, consistency, and operator ergonomics for small mechanical and electromechanical assemblies and single-use components
• Troubleshoot build and equipment issues on the line as the technical point of contact, working hands-on alongside operators
• Run the pilot line with two production operators: set build assignments, write clear procedures, train, and incorporate operator feedback
• Set up and administer the systems needed to run and mature the line, including inventory, document trails, production forecasting, project planning, and output and quality dashboards
• Mature the line beyond day-to-day builds by balancing line flow, tracking output, organizing workstations and storage, and planning facility layout
• Source and bring new and higher-volume equipment online, such as heat sealers, adhesive dispensers, and label printers, and build cost, capacity, and space models to inform decisions
• Own calibration, maintenance, supplies, and records, delegating routine work while staying accountable for results
• Write and execute validation plans, PFMEAs, IQ/OQ/PQ protocols, and test method validations for fixtures and equipment
• Support cleanroom (controlled environment room) qualification and environmental monitoring

Requirements

• BS in Mechanical or Biomedical Engineering, or equivalent hands-on experience with mechanical assembly, fixtures, and automation equipment
• 6+ years of hands-on manufacturing engineering experience
• Custom fixtures and tooling you personally designed and put into daily production use (not only specifying, ordering, or maintaining equipment)
• Direct day-to-day experience working with production operators, with clear communication, empathy, and procedures they can actually follow
• Experience on a growing or high-volume production line, including line balancing, output tracking, workstation layout, and scaling equipment
• Initiative to build systems and processes from scratch in a startup environment
• Proficiency in SolidWorks and mechanical drawings, including tolerance analysis
• Working knowledge of process validation (IQ/OQ/PQ, TMV), good documentation practices, and traceability
• Medical device experience under 21 CFR 820 and ISO 13485 strongly preferred
• Strong technical writing, spreadsheet, and organizational skills
• Motivated by building something, not by title. Comfortable owning the line now and handing it to a dedicated ops team as the company grows.
• Bonus: wearable devices, single-use disposables, or small electromechanical assemblies