Work Flexibility: Hybrid or Onsite
Stryker is seeking a Senior Engineer, Advanced Operations to support the innovation and development of new products, with a strong emphasis on manufacturing processes, technologies, and procedures required to successfully bring products to market. This role is Hybrid in Portage, Michigan.
What You Will Do
- Provide engineering support for new product and process introductions, ensuring alignment with Stryker new product development procedures.
- Ensure process and product quality in accordance with operational and material specifications.
- Assist in the selection of components and equipment based on specifications, reliability, and regulatory requirements; partner with Quality to develop testing and inspection protocols.
- Support capital equipment acquisition, including specification, vendor engagement, installation, and validation.
- Analyze equipment performance, conduct experimental testing, and interpret results to drive process improvements.
- Lead and/or participate in process reviews and cross-functional discussions.
- Contribute to PFMEA, Control Plans, SOPs, and PPAP activities for product transfers and launches.
- Conduct capability studies, MSA, and develop inspection documentation for in-process controls.
- Train manufacturing team members on new processes and procedures.
- Ensure compliance with GMP, safety requirements, and validation documentation reviews.
What You Need
- Bachelor’s degree in Electrical Engineering or related engineering discipline
- 2+ years of relevant post-graduate engineering experience
- Experience working in an FDA-regulated or similarly regulated industry
- Knowledge of manufacturing processes, materials, and product/process design
Preferred