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Advanced Operations Technical Lead
1 week ago
In this role, you will independently determine and develop approaches to technical problems of moderate scope and complexity. The Advanced Operations Technical Lead will utilize the latest engineering techniques to reduce product time to market while adhering to regulatory requirements, project deadlines, and product costs.
Main Responsibilities:- Provide engineering support for new product and process introductions, ensuring all activities are completed and documented according to Stryker's new product development procedures.
- Evaluate the quality of processes and products as specified in operation and material specifications.
- Select components and equipment based on an analysis of specifications, reliability, and regulatory requirements. Work closely with quality engineers to develop component-specific testing and inspection protocols.
- Lead capital acquisition activities from specifying equipment, contract negotiation, installation, and validation.
- Analyze equipment to establish operating data, conduct experimental tests, and result analysis. Participate in process review meetings.
- Contribute to 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 approve validation documentation.