As a Senior Compliance Engineer, you will be responsible for educating the business on all aspects of compliance with US and international standards and regulations governing the manufacturing and selling of our products. You will also be responsible for facilitating the approvals process to gain and maintain market access. You will be the system expert on test lab capabilities with respect to approvals testing processes and equipment. Your primary goal is to assure product compliance while designs meet functional requirements and design inputs throughout the product life.
What You Will Do
Apply a broad knowledge of principles, practices, and procedures to verify product design conformance to US and international electrical and mechanical standards, regulations, and initiatives.
Provide direction and support to lab personnel with respect to compliance testing, design, and sustainment of engineering teams in relation to compliance issues, and 3rd party labs with respect to our product compliance testing.
Develop and execute test plans with design, quality, and test teams.
Collaborate with Electrical and Mechanical Test Engineers to ensure the correct test processes and procedures are followed to gain and maintain product compliance.
Primary responsibilities for any equipment, processes, accreditation, documentation, or audits associated with internal certification, preliminary compliance and compliance testing.
Assist in designing and installing process sampling systems, procedures, statistical techniques, testing mechanisms, and equipment associated with compliance testing.
Assist the design teams in analyzing acquired data and failures in order to provide actionable information to help improve design quality and efficiency with respect to compliance.
Evaluate, recommend, procure and/or maintain various processes, procedures, architecture, equipment, programs, instrumentation and other technologies for continuous improvements in compliance or compliance testing.
Act as a technical lead for design, sustainment engineering, and test team members, third party labs, or contractors as necessary.
What You Need (Required Qualifications)
Bachelor’s Degree in Electrical Engineering or related field.
2+ years of related experience.
Preferred Qualifications
Achieved an advanced (learning) level of industry knowledge
Competent with Microsoft Office (Outlook, Excel, Word, etc.)
Demonstrated competence and a beginner’s level of expertise in product design theory and application as applied specifically to electrical hardware and architecture, microcontroller, microprocessor, wireless technologies, embedded systems but also familiarity with mechanical components and products, required.
Demonstrated competence and a beginner’s level of expertise in electrical testing equipment and processes as well as an understanding and use of dynamic analytical methods/tools for analyzing electrical, software, and mechanical platforms, required.
General knowledge of compliance with the Code of Federal Regulations is required
General knowledge of Schematic Capture and PBC Layout tools is preferred
Work within and apply any of the following standards in the development of our products (not limited to the below standards) is preferred:
IEC 60601-1 (General Safety Requirements for Medical Electrical Equipment)
IEC 60601-1-2 (EMC)
IEC 60601-2-38, 2-52 (Electrically Operated Hospital Beds)
IEC 60529 (Ingress Protection for Enclosures)
IEC 61000 Series (EMC Testing Techniques)
UL 60601-1 (Medical Electrical Equipment)
UL 746C (Polymeric Material Used In Electrical Equipment)
UL 1069 (Hospital Signaling and Nurse Call Equipment)
Additional ISO/AAMI Related Standards as required
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.