Senior Compliance Engineer supporting EMC testing and compliance for new product development at Stryker Medical. Collaborating with teams to ensure regulatory compliance throughout product lifecycle.
Responsibilities
Support electromagnetic compatibility testing and compliance activities for new product development and/or sustaining engineering.
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.
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.
Requirements
Bachelor’s degree in electrical engineering or related discipline.
2+ years of experience required.
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).
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