Stryker Hiring for Senior Product Safety Engineer at Portage, MI Full Time

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker’s engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

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.

What You Will Do:

• Work with Research and Development (R&D) teams to define and implement a product safety program plans for large, complex development programs for the Neurosurgical business unit within Stryker Instruments.
• 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.
• Creates product safety test plans, and ensures 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.
• Interacts and works with nationally Recognized Test Labs (NRTLs) and external organizations to meet certification requirements for our products. Also, ensures that the test plans developed by the Product Safety team can be completed.
• 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.
• Serve as a Consultant for all compliance related issues effecting new product development or existing product engineering.
• 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 2 years of engineering experience

Preferred Qualifications:

• Possess an understanding of IEC standards and understanding of compliance or related regulatory compliance standards.
• Viewed as a divisional resource in area of expertise.
• 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)

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com