Senior Process Engineer, Advanced Operations
About The Position
Stryker is seeking a Senior Process Engineer to join its OrthoTech Division in an onsite role in Portage, Michigan. The position supports new product and process introductions, process development and validation across the supply chain, and the quality and reliability of manufacturing processes and products. The engineer works with designers, suppliers, manufacturing teams, and other cross-functional partners to meet project needs and business strategy while following Stryker procedures, quality system requirements, GMP, and safety procedures. The role includes approximately 10% travel between Stryker engineering and manufacturing sites and key supplier sites as needed.
Requirements
- Bachelor’s degree in engineering.
- At least 2 years of applicable full-time work experience.
- Working knowledge of PFMEA.
- Strong technical documentation skills and the ability to communicate technical details effectively to a cross-functional audience.
- Excellent analytical skills and the ability to plan, organize, and implement concurrent tasks.
- Good knowledge of machining, manufacturing, and assembly processes; materials; and product and process design.
- Ability to read and interpret complex engineering drawings and understand GD&T.
- Ability to learn and apply quality system procedures and best practices.
- Strong interpersonal and communication skills for cross-functional internal and external conversations.
- Willingness to travel between Stryker engineering and manufacturing sites and key supplier sites as needed.
- CAD experience.
Responsibilities
- Support new product and process introductions, ensuring activities are completed and documented according to Stryker new product development procedures.
- Ensure process and product quality.
- Support supply chain architecture and implementation to meet project needs and business strategy.
- Own process development and validation for the entire supply chain.
- Partner with designers and suppliers to communicate design-for-manufacturing (DFM), design-for-assembly (DFA), and design-for-inspection (DFI) considerations.
- Select components and equipment based on specifications, reliability, and regulatory requirements.
- Develop testing and inspection equipment and protocols.
- Lead or support capital acquisition, including equipment specification, contract negotiation, installation, and validation.
- Analyze equipment to establish operating data and conduct experimental testing and results analysis.
- Lead or participate in process review meetings.
- Own process risk documentation, including PFMEA and PCP, and validation planning and execution according to Stryker quality system requirements.
- Complete engineering studies such as DOE, MSA, and capability studies for component and assembly manufacturing and inspection processes.
- Provide training for manufacturing team members.
- Ensure adherence to GMP and safety procedures.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
