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JOB DESCRIPTION

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Stryker is seeking a Senior Manager, Compliance Engineering within our Medical Division. This is a hybrid position located in Portage, MI.
As the Senior Manager, Compliance Engineering you will lead the Compliance Engineering function, ensuring all products meet applicable regulatory and industry standards for safety, electromagnetic compatibility (EMC), wireless performance, and electrical compliance. This role provides strategic and technical leadership in compliance testing and certification processes, with a strong focus on IEC 60601 series standards and applicable national and international regulations.
This position sits within the RAQAC Business as part of the Systems and Technical Solutions team, a shared service supporting multiple business units within the Medical Division.

• Lead and develop a high-performing Compliance Engineering team, including EMC, Safety, and Wireless engineers.
• Ensure product compliance with standards such as IEC 60601 and regional/national deviations (e.g., ANSI/AAMI, CAN/CSA, EN, JIS).
• Develop and execute optimized test strategies using internal certified labs and external testing partners (e.g., UL, Intertek, CSA).
• Collaborate with Product Development teams to align design controls and verification plans with compliance requirements.
• Maintain and improve compliance engineering processes and SOPs aligned with ISO 13485, 21 CFR 820, and internal QMS.
• Stay current with evolving global standards and proactively update internal processes and documentation.
• Manage compliance budgets, capital equipment needs, and vendor relationships.
• Support cross-functional teams (Marketing, Operations, Service) in understanding product compliance claims and limitations.