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Staff Compliance Engineer

4 months ago

Portage, United States Stryker Full time

Work Flexibility: Hybrid or Onsite

Who we Want

  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
  • Motivated product launchers. Engineers who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
What You Will Do
  • Lead the overall wireless test & certification compliance strategy for new product development and globalization projects.
  • Drive best-in-market wireless test performance of connected ME systems and devices.
  • Grow and adapt the wireless technology & test roadmap to align with business ambition and future technology integration.
  • Support globalization of connected devices by developing standards and test method mastery for wireless applications.
  • Ensure state-of-the-art interpretation of global wireless compliance standards for medical and non-medical markets to enable globalization portfolio growth.
  • Inspire trust, build followership, and be the sought-out wireless compliance subject matter.
Wireless Domain Responsibility
  • Will be working on wireless test and certification requirements from internationally recognized standards and agencies.
  • Will translate complex rules, standards, and regulations with a high level of accuracy.
  • Will work on wireless test methodology to define and characterize wireless performance in development.
  • Will be work closely with software, mechanical, and electrical engineering disciplines to manage and sustain radio module life cycles and connected system obsolescence mgmt.
  • Influence new product development teams when defining design verification and validation test requirements to ensure design inputs and wireless test and certification requirements are met.
  • Evaluate predicate products for relevant compliance and wireless performance issues that may impact new product development projects.
  • Analyze and define wireless radio module performance and compliance attributes for product and process through risk analysis techniques.
  • Contribute to the completion of final design verification and validation wireless reports by providing concise conclusions and direction.
  • Manage 3rd party partnerships for test capability, global market access, and report/document accuracy with global certification bodies.
Additional Responsibilities
  • Exercise independent judgment in selecting techniques, methods, and approaches for engineering and technologies and socialize direction for consensus.
  • Act as independent reviewer and mentorship in design review and product development process.
  • Contribute to and influence intellectual property strategy, inventions, strategies, and review boards.
  • Provide input to system architecture and wireless test mgmt. of radio/module reuse.
  • Represent the division in corporate policy and procedure development.
  • Represent the organization at industry technical forums and committee participation.
  • Seek to teach and learn from other Compliance, Test & R&D Engineers.
  • Participate in customer-facing activities like VOC, CPT, BETA test, and CCD.
  • Drive financial modeling efforts on new capabilities or emerging technologies.
  • Influence, and advance Stryker's position in the industry by influencing the development of standards and regulations working across business units.
What You Need

Minimum Requirements(Must Haves)
  • Bachelor's degree in electrical engineering, Biomedical Engineering or related discipline with 4+ years of experience
  • 4+ years' experience with RF Testing and regulatory certification for major regulatory authorities which may include FCC (US), ISED (Canada), CE (EU), MIC (Japan) and others.
Preferred requirements(Nice to Haves)
  • Preferred experience with medical device product development lifecycle, including risk management.
  • Experience working with and managing third-party certification labs. (UL, TUV, CSA, Intertek).
  • Knowledge of wireless technologies and related industry standards, such as Wi-Fi, Bluetooth, etc.
  • Experience with device regulatory certification on all aspects of wireless, EMC and safety standards.
  • Familiarity with RF conducted and radiated measurements.
  • Basic knowledge of regulatory certification and device submission processes.
  • Must possess strong project management and collaboration skills.
  • Demonstrated ability to advocate for product excellence and compliance.
  • Demonstrated ability to effectively work cross-functionally with other departments, including Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
  • Strong interpersonal skills, written, oral communication and negotiation skills.
  • Able to balance business and technical challenges to achieve financial outcomes.
  • Demonstrated ability to successfully manage and complete projects in a matrix organization.
  • Demonstrated ability to work independently.
  • Experience in working in a compliance risk environment.


Travel: Up to 20%

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.