Senior Manufacturing Engineer

Work Flexibility: OnsiteThe Senior Manufacturing Engineer leads and coordinates the fabrication, installation, operation, maintenance, and repair of mechanical and electromechanical manufacturing systems. The position ensures quality and industry standards are consistently met or improved while driving efficiency, evaluating equipment performance and cost-effectiveness, and recommending design or process modifications to enhance reliability and reduce malfunctions. This is an onsite role in Ventura, California.What You Will DoDesign, develop, and validate manufacturing processes (IQ/OQ/PQ) for new and existing medical device product linesDevelop and maintain process FMEAs, control plans, and work instructionsLead root cause analysis (RCA) and corrective/preventive action (CAPA) investigations for manufacturing nonconformancesApply Lean and Six Sigma methodologies to reduce defects, cycle time, and manufacturing costsPartner with R&D to ensure design-for-manufacturability (DFM) during new product development and Design Transfer activitiesCollaboration with Regulatory Affairs and Quality on technical filesDefine equipment specifications; lead procurement, installation, and commissioning of manufacturing equipmentMaintain calibration and preventive maintenance programs for production equipmentEnsure manufacturing documentation (DHR, DMR, batch records) is complete, accurate, and inspection-readySupport internal, customer, and regulatory audits (FDA, Notified Body); prepare responses to audit findingsMaintain compliance with FDA, ISO 13485, and ISO 14971 requirementsWhat You NeedBachelor’s degree in Mechanical engineering, Biomedical Engineering, Industrial Engineering, or related disciplineMinimum 5 years of engineering experience in a regulated medical device manufacturing environmentHands-on experience with process validation (IQ/OQ/PQ) and Design TransferWorking knowledge of ISO 13485 quality management systemsProficiency with statistical analysis and process capability tools (e.g., Cpk, Gage R&R)Experience authoring engineering documentation, including SOPs, work instructions, and validation protocolsPreferredMaster’s degree in Engineering (Mechanical, Biomedical, Industrial, or related field)Six Sigma Green Belt or Black Belt certificationExperience supporting Class II or Class III medical devicesFamiliarity with ISO 14971 risk management and FMEA methodologiesProficiency with CAD tools (e.g., SolidWorks) and ERP/MES systemsExperience supporting FDA inspections or Notified Body auditsKnowledge of sterilization methods (EtO, gamma, e-beam) or cleanroom manufacturingUnited States of America Pay Ranges:US10: $ 85,500.00 - 142,500.00 USD AnnualView the U.S. work location and transparency guide to find the pay range for your location.Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.SummaryLocation: Ventura, CaliforniaType: Full time