• Job Description

  Req#: R540871
  Work Flexibility: Hybrid

  Stryker is hiring a Staff Compliance Engineer to support our Emergency Care division. The work schedule is structured to support flexibility, with in-office presence required Monday through Wednesday and remote work available on Thursday and Friday.

  As Staff Compliance Engineer, you will evaluate new and revised electro-medical devices and accessories to international safety standards. Interfacing with project teams and other departments, you will create and maintain evaluation and certification reports, as well as Technical Documentation files including reviewing IEC test procedures and reports, ensuring compliance with safety standards and requirements, conducting in-house and external testing, and managing certifications and requirement checklists.

  Responsibilities:

  • Review and evaluate test data, specifications, engineering and user documentation, physical construction, marking and labeling, hazard analysis, clinical reports, Declaration of Conformity, EMC protocol and test reports, and technical descriptions of essential components and materials

  • Lead the preparation and revision of Technical Document Files and other certification reports from engineering documentation

  • Create and maintain overall isolation diagrams

  • Guide engineering project teams in designing new or revised products to ensure compliance

  • Manage several projects and collaborate with internal and external department teams

  • Provide weekly status reports

  • Implement complex engineering documentation

  • Develop design and process changes under the direction of senior engineers

  • Manage the administration of ISO17025 CTF3 Data Acceptance Program between the verification lab and NRTL

  What you need

  Required

  • Bachelor's degree in biomedical, electrical, or mechanical engineering or related discipline

  • Minimum 4 years’ experience with safety standards, product compliance, and certifications

  Preferred

  • Familiarity with IEC standards for medical devices, such as IEC 60601-1 and IEC 60601-2-4, ISO 17025, ISO 14971, CE-Mark, Technical Documentation Files, and safety agencies like UL, CSA, TUV, and BSI

  • Knowledge of high-voltage circuits and isolation

  • Experience with test and measurement equipment operation such as dielectric, leakage, and ground impedance testers and DVMs

  • Understanding of basic analog circuits and components

  $100,700.00 - $165,100.00 USD Annual salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

  Travel Percentage: 0%

  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.

• About the company

  Stryker Corporation is an American multinational medical technologies firm based in Kalamazoo, Michigan.

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