Senior Engineer, Advanced Operations
Job Description
Who we want-
- Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
- Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
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 Chandler, AZ.
This role supports the execution of assigned project elements with an emphasis on the manufacturing process, technology and procedures required for the manufacture of new products.
What you will do-
- 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
- Assist in the selection of components and equipment based on analysis of specifications, reliability and regulatory requirements
- Support capital acquisition activities
- Analyze equipment to establish operating data, conduct experimental test and result analysis and 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 validation and MSA studies for new products and new processes
- Work in a hands-on manner at the manufacturing site to support the implementation of new processes as specified in development
- Provide training for manufacturing team members
- Ensure adherence to GMP and safety procedures
What you need-
- Bachelor's Degree in Engineering or relevant field required
- A minimum of 2 years of relevant work experience required
- Basic knowledge of manufacturing processes, materials, product and process design - preferred
- Ability to read and interpret complex engineering drawings and have understanding of geometrical dimensioning and tolerancing - preferred
- Experience in an FDA regulated or regulated industry beneficial - preferred