Staff Process Engineer, Advanced Operations
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 Apply tot his job