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Senior Staff Compliance Engineer - Wireless
StrykerUnited 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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