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. The core of the role is engineering: fixtures, equipment and process improvement. You'll also run a small pilot line and supervise two operators. Over the next 1–2 years, as the company builds a full operations team, the role will shift toward scale-up and automation.

San Diego, CA | Onsite

$130K–$160K base + + bonus & equity

Responsibilities

• Own the pilot line, supervising two production operators, including scheduling and build assignments
• Plan production builds and material inventory: forecast demand, place orders, and track output and quality against plan
• Own calibration, maintenance, supplies and records, delegating routine work while staying accountable for results
• Design and build fixtures and equipment for small electromechanical devices and single-use components
• Drive process improvements for yield and efficiency, and monitor performance with control charts and statistical tools
• Source and bring new equipment online, such as heat sealers, adhesive dispensers and label printers
• Build cost, capacity and space models to inform equipment decisions and future lines
• Serve as the technical point of contact for the line, troubleshooting build and equipment issues
• Write validation plans and PFMEAs, and write and execute IQ/OQ/PQ protocols and test method validations
• Support cleanroom (controlled environment room) qualification and environmental monitoring

Requirements

• BS in Mechanical Engineering or a related field
• 6+ years of hands-on manufacturing engineering experience
• Direct experience with production operators: training, troubleshooting and writing procedures they can follow
• Fixtures you designed that went into daily production use
• Medical device experience with working knowledge of 21 CFR 820 and ISO 13485 strongly preferred
• Fluency with good documentation practices, process validation, audits and traceability
• Proficiency in SolidWorks and mechanical drawings for fixtures and tooling
• Strong technical writing, spreadsheet and organizational skills
• Bonus: small electromechanical assemblies, single-use disposables or wearable devices
• Comfortable supervising operators and thriving in a small, fast-moving team