Staff Process Engineer, Advanced Operations
About The Position
Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures Ensure quality of process and product as defined in the appropriate operation and material specifications Drive and execute effective communication with all stakeholders to enable project success Assist in the selection of components and equipment based on analysis of specifications, reliability, and regulatory requirements Lead/support capital acquisition activities, including specifying equipment, contract negotiation, installation, and validation Write operations manuals, troubleshooting manuals, continuous and preventive maintenance manuals Analyze equipment to establish operating data and conduct experimental test and result analysis Lead/participate in process review meetings Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches Complete capability studies for in-process inspection and generate subsequent inspection documentation Conduct qualifications, validations, and MSA studies for new products and new processes. Review and approve validation documentation Work in a hands-on manner at the manufacturing site to support the implementation of new processes as specified in development Provide training for manufacturing team members Ensure adherence to GMP and safety procedures
Requirements
- 4+ years of relevant work experience - required
- Bachelor's Degree in Engineering - required
Nice To Haves
- Bachelor's degree in Industrial or Systems Engineering - highly preferred
- Lean Six Sigma Green Belt Certification or above - preferred
- Knowledge of manufacturing processes, materials, product, and process design - preferred
- Good understanding of design for manufacturing (DFM), related statistical tools, and validation/verification techniques - preferred
- Ability to read and interpret complex engineering drawings and have understanding of geometrical dimensioning and tolerancing - preferred
- Experience writing and executing validations - preferred
- Experience in new production introduction or manufacturing engineering - preferred
- Experience in an FDA regulated or regulated industry - preferred
Responsibilities
- Provide engineering support for new product and process introductions
- Ensure quality of process and product
- Drive and execute effective communication with all stakeholders
- Assist in the selection of components and equipment
- Lead/support capital acquisition activities
- Write operations manuals, troubleshooting manuals, continuous and preventive maintenance manuals
- Analyze equipment to establish operating data and conduct experimental test and result analysis
- Lead/participate in process review meetings
- Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches
- Complete capability studies for in-process inspection and generate subsequent inspection documentation
- Conduct qualifications, validations, and MSA studies for new products and new processes. Review and approve validation documentation
- Work in a hands-on manner at the manufacturing site to support the implementation of new processes as specified in development
- Provide training for manufacturing team members
- Ensure adherence to GMP and safety procedures
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Miscellaneous Manufacturing
Number of Employees
5,001-10,000 employees
