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Senior Staff Compliance Engineer - Wireless

Stryker
United Statesfull_timeVerifiedPosted 2 Aug 2024

About the role

Work Flexibility: Hybrid

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

  • Lead compliance programs for wireless test and certification requirements from internationally recognized standards and agencies.
  • Translate complex requirements, 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.
  • Oversight and review 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 Qualifications (Required):

  • Bachelor’s degree in electrical engineering, Biomedical Engineering or related discipline with 6+ years of applicable experience
  • 6+ 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 Qualifications (Strongly desired):

  • 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

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Company

Stryker

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