Senior/Staff Manufacturing Engineer

Job Description

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

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Summary

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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.

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San Diego, CA | Onsite

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$130K–$160K base + + bonus & equity

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Responsibilities

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

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