Senior Compliance Engineer, EMC

StrykerDetroit, MI
9dOnsite

About The Position

Stryker is seeking a Senior Compliance Engineer, EMC to support electromagnetic compatibility testing and compliance activities for new product development and/or sustaining engineering, contributing to successful global product launches and ongoing regulatory compliance for Stryker Medical. Develop and execute EMC test plans and support design reviews. Apply EMC standards and test methods for medical devices, building proficiency in IEC 60601‑1‑2 and related global requirements. Collaborate with design, quality, and regulatory teams to identify and resolve EMC compliance needs throughout the product lifecycle. This role is an individual contributor position focused on developing technical depth in EMC testing, standards application, and compliance processes. The EMC Engineer builds hands-on expertise through testing, analysis, and cross-functional collaboration while growing toward increased technical knowledge and responsibility. What You Will Do Compliance Engineering – EMC Domain responsibilities Lead end-to-end EMC compliance Strategy for new product development programs and/or sustainment programs within Stryker Medical Review designs with subject matter experts to develop EMC compliance plans and collaborate with design engineers to imprint good EMC design practices early in the design cycle. Analyze designs for adherence to good EMC design practices. Develop streamlined EMC evaluations utilizing design, data, and risk-based evaluations. Diagnose root cause of EMC compliance issues and propose mitigation actions. Translate global EMC standards into clear requirements. Manage and influence third-party certification labs and NRTL partners to support global market access and meet quality, cost, and schedule expectations. Leadership & Organizational Impact Serve as the project lead for new product development and/or sustainment programs within Stryker Medical. Exercise independent judgement in selecting compliance strategies and socialize direction to build alignment and consensus. Drive design for EMI/EMC processes, and best practices across disciplines. Travel Up to 20%, as required to support projects, partners, and industry engagement. What You Need (Required Qualifications) Bachelor’s degree in electrical engineering or related discipline. 2+ years of experience required. Preferred Qualifications Experience with product safety regulatory certification for major standards bodies and frameworks (e.g., IEC, AAMI, and related schemes). Experience with medical device product development lifecycle, including design controls and risk management. Experience working with and managing third-party certification laboratories (e.g., UL, TÜV, CSA, Intertek). Experience with device regulatory certification involving safety, EMC, and/or wireless standards. Demonstrated ability to work independently and effectively in a matrixed organization. Strong written, verbal, and interpersonal communication skills with the ability to influence without authority. Travel Percentage: 20% 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. Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.

Requirements

  • Bachelor’s degree in electrical engineering or related discipline.
  • 2+ years of experience required.

Nice To Haves

  • Experience with product safety regulatory certification for major standards bodies and frameworks (e.g., IEC, AAMI, and related schemes).
  • Experience with medical device product development lifecycle, including design controls and risk management.
  • Experience working with and managing third-party certification laboratories (e.g., UL, TÜV, CSA, Intertek).
  • Experience with device regulatory certification involving safety, EMC, and/or wireless standards.
  • Demonstrated ability to work independently and effectively in a matrixed organization.
  • Strong written, verbal, and interpersonal communication skills with the ability to influence without authority.

Responsibilities

  • Lead end-to-end EMC compliance Strategy for new product development programs and/or sustainment programs within Stryker Medical
  • Review designs with subject matter experts to develop EMC compliance plans and collaborate with design engineers to imprint good EMC design practices early in the design cycle.
  • Analyze designs for adherence to good EMC design practices.
  • Develop streamlined EMC evaluations utilizing design, data, and risk-based evaluations.
  • Diagnose root cause of EMC compliance issues and propose mitigation actions.
  • Translate global EMC standards into clear requirements.
  • Manage and influence third-party certification labs and NRTL partners to support global market access and meet quality, cost, and schedule expectations.
  • Serve as the project lead for new product development and/or sustainment programs within Stryker Medical.
  • Exercise independent judgement in selecting compliance strategies and socialize direction to build alignment and consensus.
  • Drive design for EMI/EMC processes, and best practices across disciplines.
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