· 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.
· Will assist in the selection of components and equipment based on analysis of specifications, reliability, and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
· Support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
· Will analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/or 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 MSA studies for new products and new processes.
· Provide training for manufacturing team members.
· Ensure adherence to GMP and safety procedures.
· Review and approval of validation documentation.
All other duties as assigned.
Travel Percentage: 0%