Staff Process Engineer, Advanced Operations bei Stryker
Stryker · Tempe, Vereinigte Staaten Von Amerika · Hybrid
- Senior
- Optionales Büro in Tempe
What you will do-
- 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
What you need-
- 4+ years of relevant work experience – required
- Bachelor's Degree in Engineering – required
- 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