Senior Manager, Compliance Engineering (Hybrid)
Senior Manager, Compliance Engineering (Hybrid)
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Job Description
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 onIEC 60601 series standardsand applicable national and international regulations.
This position sits within theRAQAC Businessas part of theSystems and Technical Solutions team a shared service supporting multiple business units within theMedical Division.
What you will do
Lead and develop a high-performing Compliance Engineering team including EMC Safety and Wireless engineers.
Ensure product compliance with standards such asIEC 60601and 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 withISO 1348521 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.
What you need
Required
Bachelors degree in an Engineering-related discipline
10 years of experience in Engineering Quality or Regulatory disciplines
4 years of people management experience
Preferred
Experience in FDA-regulated or highly regulated environments
Deep understanding of IEC standards for medical devices especiallyIEC 60601-1andIEC
Skilled performance coach with experience in setting clear objectives and managing team performance
Strong familiarity with technical documentation files and safety agencies (UL CSA TUV CB-Scheme)
Proven ability to deliver programs or business goals on time within budget and to quality standards
Required Experience:
Senior Manager
Employment Type
Full-Time
