Senior Manufacturing Engineer

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.~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.~Position SummaryThe 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.~Key ResponsibilitiesLead manufacturing efforts for new product introductions (NPI) through production launchDefine manufacturing strategies, process flows, and production readiness plansDesign and deploy assembly processes, tooling, fixtures, and test equipmentDrive DFM/DFA initiatives with product development teamsLead process validation (IQ/OQ/PQ), DOE, and data-driven improvementsTroubleshoot production issues and lead root cause investigationsImplement engineering changes (ECOs) and support CAPA activitiesDevelop scalable production lines, workflows, and work instructionsCollaborate with Quality and Regulatory to ensure GMP/FDA complianceSupport supplier qualification and technology transfer to contract manufacturersMentor junior engineers and support audits/inspections~QualificationsBachelor's degree in Engineering (Mechanical or related; Master's preferred)6+ years of manufacturing/process engineering experience (medical device or regulated industry preferred)Strong background in DFM/DFA, process validation, and DOEExperience with NPI, production scaling, and contract manufacturersProficiency in 3D CAD (SolidWorks or similar)Hands-on problem solver with strong analytical and communication skillsExperience with ISO 9001 or regulated quality systems~Nice to HaveExperience with disposable devices or cleanroom manufacturingLean / Six Sigma training or certification