Stryker Corporation
Senior Engineer, Manufacturing Engineering
Stryker Corporation, Irvine, California, United States, 92713
Senior Engineer, Manufacturing Engineering page is loaded## Senior Engineer, Manufacturing Engineeringlocations:
Irvine, Californiatime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R556119Work Flexibility: OnsiteSenior Manufacturing Engineer will lead sustaining engineering activities to ensure safe, compliant, and efficient manufacturing of medical devices. This role will be responsible for driving continuous improvement, troubleshooting production issues, and supporting change management activities while ensuring adherence to internal quality system requirements. The role partners closely with Operations, Quality, R&D, and Suppliers to improve yield, optimize processes, and support product lifecycle objectives. Team members shall receive minimal supervision and are viewed as subject matter experts.**What you will do:*** Lead and execute process validation activities, IQ/OQ/PQ, for manufacturing processes, equipment, and test methods to ensure continued compliance and product quality.* Develop, author, review, and approve validation protocols, reports, and supporting manufacturing documentation meeting internal quality system requirements.* Assess and implement revalidation strategies driven by process changes, non-conformances, CAPAs, production metric trends, or continuous improvement initiatives.* Troubleshoot manufacturing production and equipment issues related to existing established processes and directly work with cross-functional team members to implement corrective actions.* Directly support change management activities, which will include performing risk assessments and assessing the impact on validated processes and products, equipment, and material changes.* Support and drive Quarantine Ticket (QT) and Non-conformance (NC) report dispositions and investigations.* Support Kaizen and continuous improvement events.* Participate in internal/external audits by providing validation expertise and general guidance on existing manufacturing processes.* Mentor entry-level to junior engineers and provide technical guidance.**Minimum Qualifications:*** Bachelor’s degree in mechanical engineering, biomedical engineering, or a related discipline.* Minimum 2 years of engineering experience.**Preferred Qualification:*** Catheter and/or medical device* Proficiency in SolidWorks for creating and modifying production-released models and drawings.* Experience designing manufacturing fixtures, gauges, and test setups.* Understanding of design for manufacturing (DFM) principles to support yield improvements and manufacturing robustness.* Capable of performing tolerance analysis and stack-ups.Travel Percentage: 20%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. #J-18808-Ljbffr
Irvine, Californiatime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R556119Work Flexibility: OnsiteSenior Manufacturing Engineer will lead sustaining engineering activities to ensure safe, compliant, and efficient manufacturing of medical devices. This role will be responsible for driving continuous improvement, troubleshooting production issues, and supporting change management activities while ensuring adherence to internal quality system requirements. The role partners closely with Operations, Quality, R&D, and Suppliers to improve yield, optimize processes, and support product lifecycle objectives. Team members shall receive minimal supervision and are viewed as subject matter experts.**What you will do:*** Lead and execute process validation activities, IQ/OQ/PQ, for manufacturing processes, equipment, and test methods to ensure continued compliance and product quality.* Develop, author, review, and approve validation protocols, reports, and supporting manufacturing documentation meeting internal quality system requirements.* Assess and implement revalidation strategies driven by process changes, non-conformances, CAPAs, production metric trends, or continuous improvement initiatives.* Troubleshoot manufacturing production and equipment issues related to existing established processes and directly work with cross-functional team members to implement corrective actions.* Directly support change management activities, which will include performing risk assessments and assessing the impact on validated processes and products, equipment, and material changes.* Support and drive Quarantine Ticket (QT) and Non-conformance (NC) report dispositions and investigations.* Support Kaizen and continuous improvement events.* Participate in internal/external audits by providing validation expertise and general guidance on existing manufacturing processes.* Mentor entry-level to junior engineers and provide technical guidance.**Minimum Qualifications:*** Bachelor’s degree in mechanical engineering, biomedical engineering, or a related discipline.* Minimum 2 years of engineering experience.**Preferred Qualification:*** Catheter and/or medical device* Proficiency in SolidWorks for creating and modifying production-released models and drawings.* Experience designing manufacturing fixtures, gauges, and test setups.* Understanding of design for manufacturing (DFM) principles to support yield improvements and manufacturing robustness.* Capable of performing tolerance analysis and stack-ups.Travel Percentage: 20%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. #J-18808-Ljbffr