• Staff Compliance Engineer - Wireless

    StrykerPortage, MI 49024

    Job #2708965007

  • We are excited to be named one of the World's Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually, as well other great perks. For an overview of our benefits and time off, please follow this link to learn more: US Stryker employee benefits. (~~~)

    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%

    Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

    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.

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