Senior Engineer, Manufacturing Engineering

Irvine, CA - USA

Monthly Salary: Not Disclosed

Posted on: 3 days ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Onsite

Senior 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:

Bachelors 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 contractors legal duty to furnish information.

Required Experience:

Senior IC

Work 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 manageme...

Work Flexibility: Onsite

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:

Bachelors 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%

Required Experience:

Senior IC

Key Skills

Engineering Support
Front Office Management
Art & Design
Airlines
Jboss
Clinical

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About Company

Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more

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