Stryker Medical’s Advanced Operations team plays a key role in bringing new products into manufacturing. As a Senior Staff Engineer, you will provide process engineering leadership during design transfer, equipment implementation, and process development activities, partnering across engineering, quality, manufacturing, and regulatory teams to support successful product launches in a regulated environment.
What You Will Do:
Lead process engineering activities for new product introductions, ensuring manufacturing readiness and compliance with design transfer requirements. Develop and implement manufacturing processes, methods, and controls that meet product quality, cost, and schedule objectives. Create and support process risk assessments, control plans, manufacturing procedures, and production validation activities for new product launches. Evaluate, select, procure, install, and validate manufacturing equipment and capital assets to support production requirements. Analyze process and equipment performance through testing, data collection, measurement system analysis, and experimental studies to optimize manufacturing outcomes. Develop inspection methods, test protocols, and manufacturing controls to ensure products meet defined specifications and regulatory requirements. Provide technical guidance on manufacturing standards, design requirements, testing strategies, and regulatory expectations while mentoring engineers and project teams. Partner with Research & Development, Quality, Manufacturing, Regulatory Affairs, Marketing, and Project Management teams to resolve technical challenges and achieve project milestones.
What You Will Need:
Required Qualifications Bachelor's Degree in Engineering or a related technical discipline. Minimum 6 years of experience in process engineering, manufacturing engineering, advanced operations, or a related technical field. Experience interpreting system drawings involving mechanical, electrical, and software interactions.
Preferred Qualifications:
Experience in an FDA-regulated industry or other highly regulated manufacturing environment. Experience reading and interpreting engineering drawings, including geometric dimensioning and tolerancing (GD&T). Certification(s) in Project Management, LEAN, Six Sigma, Operational Excellence, and/or related. $102,600 - $171,000 USD Annual
