Project Engineer - Validation

at  Stryker

We are excited to be named one of the World’s Best Workplaces by Fortune Magazine!
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Join our team as a Project Engineer – Manufacturing Engineering at Stryker’s new greenfield manufacturing site, where you’ll play a pivotal role in ensuring that our medical devices meet the highest standards of safety and quality. As a skilled and detail-oriented Validation Engineer, you’ll collaborate with process engineers, quality assurance teams, and validation representatives to guarantee that every aspect of the product transfer process is compliant with regulatory requirements, optimized for performance, and meticulously documented. If you thrive in dynamic environments and enjoy contributing to innovative projects in a team-oriented setting, this is the opportunity for you.

• Regulatory Compliance & Collaboration: Collaborate with cross-functional teams to ensure project compliance with regulatory standards and optimize performance.
• Specification & Procurement Support: Develop User Requirements Specifications and assist in device procurement, development, and commissioning.
• Validation Management: Lead validation efforts by creating and managing FAT, SAT, IQ, OQ, OQ-P, EQ, and PQ processes in the Val-G database, ensuring thorough documentation.
• Process Consistency & System Evaluation: Ensure manufacturing processes yield consistent, reproducible results; evaluate systems, conduct tests, and document findings to meet company and regulatory standards.
• Protocol & Validation Leadership: Manage protocol approval sessions with Validation Representatives, support the Product Transfer Process team, and serve as the validation expert for ISO 13485 compliance.
• Change Management & Documentation: Initiate and upload PFD PFMEA, PCP, DMR, DHR, PRT, ECR, and ECN documents to onePLM, ensuring timely release and updates.
• Training & Coordination: Develop and execute training plans for Capability, MSA, and other processes, coordinating with Process Engineers for timely document release and training plans in onePLM.