Senior Staff Product Safety Engineer

1 week ago

Cork, Cork, Ireland Stryker Group Full time

Who We Want:

  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
  • Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

The Senior Staff Engineer - Product Safety will help bring to market our next generation of industry leading products across the Stryker Instruments portfolio. In this role, you will work with a cross-functional leadership team to support the development and execution of the Product Safety organization's strategic vision, enabling the consistent execution of safety activities for all products throughout the entire product life-cycle. You will be a recognized expert and leader within the specialized field of Product Safety engineering, demonstrating passion for system design and mentoring others.

What You Will Do:

  • Work with Research and Development (R&D) teams to define and implement product safety program plans for large, complex development programs for assigned business units within Stryker Instruments.
  • Own, lead and drive product safety activities for New Product Development, Product Engineering and Operations teams to ensure compliance of our products to the global safety requirements.
  • Lead design analysis to support the development of products within the boundaries of safety standards. Partner with R&D on identification of problems and solutions, analysis, and implementation of design elements relevant for product safety.
  • Work with Product Safety leadership to represent and advance the interests of the product safety community across all business units to executive leadership, including both technical and organizational initiatives.
  • Possesses and applies a broad knowledge of principles, practices, and procedures for product design conformance to US and international electrical and mechanical product safety 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 product safety issues and testing.
  • Create product safety test plans, and ensure that the plans can be completed and meet the needs of 3rd party certifier's requirements with respect to our internal product safety testing.
  • Support technical education in the Product Safety Engineering discipline.
  • Support maintaining a framework for developing early-career engineers in the Product Safety engineering discipline.
  • Drive to complete product safety tasks, set priorities with project team and management, and drive solutions.
  • Own, lead and drive product safety test plans and execution. Collaborate with EMC/Wireless engineering team and the lab for EMC/Wireless test executions.
  • Lead, drive and direct testing activities with nationally recognized test labs (NRTLs) and external organizations to meet timely certification requirements for our products.
  • Promote a robust product safety culture across the varied product area engineering teams. Provide strategic technical leadership in support of resolving complex safety considerations in all phases of a product's life-cycle (e.g. development, test, and operation).
  • Support senior members of the product safety team in leading projects to successful outcomes.
  • Steer future technology roadmaps by participating in technology/methodology trade studies and research/development programs.
  • Follow and mentor others on R&D procedures like design controls, change controls, and risk management, per the Quality Management System.
  • Actively participate within design teams to drive not only product safety and compliance, but also industry best practices to ensure safe and effective products for health care providers and patients.

What You Will Need:

Basic Qualifications:

  • Bachelor's Degree in Electrical Engineering, Computer Engineering, Systems Engineering, or a related Engineering degree from an accredited college or university.
  • Minimum of 6 years engineering experience.

Preferred Qualifications:

  • Possess an understanding of IEC standards and an understanding of compliance or related regulatory compliance standards.
  • Must possess excellent oral and written communication skills.
  • Competent with Microsoft Office (Outlook, Excel, Word, etc.).
  • Demonstrated competence and an intermediate 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.
  • Work within and apply the following standards in the development of our products (not limited to the below standards):
    • IEC 60601-1 (General Safety Requirements for Medical Electrical Equipment)
    • IEC 60601-1-2 (EMC)
    • IEC 60529 (Ingress Protection for Enclosures)
    • IEC 61000 Series (EMC Testing Techniques)
    • UL 746C (Polymeric Material Used In Electrical Equipment)
    • (Audio/video, information and communication technology equipment - Part 1: Safety requirements)
    • IEC 61010-1 (Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements)
    • ISO 17025 (General Requirements For The Competence Of Testing And Calibration Laboratories)

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