Engineer, Manufacturing Engineering

Stryker • Irvine, CA • 2h ago

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.

What you will do:

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.

Minimum Qualifications:

Bachelor's degree in mechanical engineering, biomedical engineering, or related discipline.

0 years of Medical Device experience.

United States of America Pay Ranges:

? US15 : $79,900 - $127,500 USD Annual

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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

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