Senior/Staff Manufacturing Engineer

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 Solid Works 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