Sr. Manufacturing Process Engineer

Position Description 

This role executes the innovation and development of assigned project elements with an emphasis on the manufacturing process, technology and procedures required for the manufacturing of Medical Device products. 

 Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.
 
 KEY AREAS OF RESPONSIBILITY

• 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 tests, and perform 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.