Stryker
Senior Manager, Compliance Engineering (Hybrid)
Stryker, Portage, Michigan, United States, 49002
Senior Manager, Compliance Engineering
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. 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 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. What you need Required Bachelor's 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, especially IEC 60601-1 and IEC 60601-2-4 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 Travel Percentage: 10% Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.
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. 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 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. What you need Required Bachelor's 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, especially IEC 60601-1 and IEC 60601-2-4 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 Travel Percentage: 10% Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.