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 & equityResponsibilitiesOwn the pilot line, supervising two production operators, including scheduling and build assignmentsPlan production builds and material inventory: forecast demand, place orders, and track output and quality against planOwn calibration, maintenance, supplies and records, delegating routine work while staying accountable for resultsDesign and build fixtures and equipment for small electromechanical devices and single-use componentsDrive process improvements for yield and efficiency, and monitor performance with control charts and statistical toolsSource and bring new equipment online, such as heat sealers, adhesive dispensers and label printersBuild cost, capacity and space models to inform equipment decisions and future linesServe as the technical point of contact for the line, troubleshooting build and equipment issuesWrite validation plans and PFMEAs, and write and execute IQ/OQ/PQ protocols and test method validationsSupport cleanroom (controlled environment room) qualification and environmental monitoringRequirementsBS in Mechanical Engineering or a related field 6+ years of hands-on manufacturing engineering experienceDirect experience with production operators: training, troubleshooting and writing procedures they can followFixtures you designed that went into daily production useMedical device experience with working knowledge of 21 CFR 820 and ISO 13485 strongly preferredFluency with good documentation practices, process validation, audits and traceabilityProficiency in SolidWorks and mechanical drawings for fixtures and toolingStrong technical writing, spreadsheet and organizational skillsBonus: small electromechanical assemblies, single-use disposables or wearable devicesComfortable supervising operators and thriving in a small, fast-moving team