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Stryker鈥檚 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.聽

• 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.聽聽聽

• 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鈥� 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