Stryker

Compensation

Full Description

Stryker’s Sustainability Solutions Advanced Operations team is seeking to hire a Senior Engineer, Advanced Operations to work on new product introduction process development in Tempe, Arizona. WHAT YOU WILL DO: • Use engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs. • 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. • Support capital acquisition activity from specifying equipment, contract negotiation, installation and validation. • Analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings. • Participate in process failure mode and effect analysis (PFMEA), control plan, standard operating procedures (SOP) and production part approval process (PPAP) generation associated with product transfers and launches. • Complete capability studies for in process inspection and generate subsequent Inspection documentation. • Conduct process validation and MSA studies for new products and new processes. • Drive and execute effective communication with all stakeholders to enable project success. • Provide training to manufacturing team members. • Review and approval of validation documentation. WHAT YOU NEED: • 2+ years’ relevant work experience - required • Lean Six Sigma Green Belt Certification or above - preferred • Writing & Executing Validations experience - preferred • New Product Introduction or Manufacturing Engineering experience - preferred • Medical Device or regulated experience - preferred