Senior Manufacturing Engineer in Alameda

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Job Description

Curt Koland Recruiting is seeking candidates who are passionate about developing medical technologies to improve patient outcomes. Our client is a medical device innovator focused on a flagship all-in-one endoscopic platform that integrates visualization, fluid management, and tissue removal into a single system. This is an exceptional opportunity to join a dedicated team at a pivotal moment in the company's growth.

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We are looking for candidates currently living in the San Francisco Bay Area with 6 or more years of experience in the Medical Device industry or a closely related field. Candidates must possess US Work Authorization or US Citizenship. We are not able to accommodate H-1B Visa transfers at this time.

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Position Summary

The Senior Manufacturing Engineer will lead manufacturing strategy and execution for new and existing products. This role drives new product introduction, process development, and production scaling, with a strong focus on quality, manufacturability, and cost optimization. You will partner cross-functionally to bring products from development through full-scale production.

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Key Responsibilities

• Lead manufacturing efforts for new product introductions (NPI) through production launch
• Define manufacturing strategies, process flows, and production readiness plans
• Design and deploy assembly processes, tooling, fixtures, and test equipment
• Drive DFM/DFA initiatives with product development teams
• Lead process validation (IQ/OQ/PQ), DOE, and data-driven improvements
• Troubleshoot production issues and lead root cause investigations
• Implement engineering changes (ECOs) and support CAPA activities
• Develop scalable production lines, workflows, and work instructions
• Collaborate with Quality and Regulatory to ensure GMP/FDA compliance
• Support supplier qualification and technology transfer to contract manufacturers
• Mentor junior engineers and support audits/inspections

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Qualifications

• Bachelor’s degree in Engineering (Mechanical or related; Master’s )
• 6+ years of manufacturing/process engineering experience (medical device or regulated industry )
• Strong background in DFM/DFA, process validation, and DOE
• Experience with NPI, production scaling, and contract manufacturers
• Proficiency in 3D CAD (SolidWorks or similar)
• Hands-on problem solver with strong analytical and communication skills
• Experience with ISO 9001 or regulated quality systems

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Nice to Have

• Experience with disposable devices or cleanroom manufacturing
• Lean / Six Sigma training or certification

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