Senior Manager, Compliance Engineering (Hybrid)

Work Flexibility: Hybrid

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 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, especiallyIEC 60601-1andIEC 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 Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.