Engineer, Manufacturing Engineering

Stryker • Irvine, CA

1d • Onsite

About The Position

The Manufacturing Engineering will support 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.

Requirements

• Bachelor’s degree in mechanical engineering, biomedical engineering, or related discipline.
• 0 years of Medical Device experience.

Responsibilities

• 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.
• Support assessment of implementation of revalidation strategies driven by process changes, non-conformances, CAPAs, production metrics trends or continuous improvement initiatives.
• Troubleshoot manufacturing production and equipment issues related to existing establish processes and directly work with cross functional team members to implement corrective actions.
• Directly support management activities that will include performing risk assessments, impact on validated processes and products, equipment, and material changes.
• Support 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 provide general guidance on existing manufacturing processes.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level