Senior Staff Product Safety Engineer (Hybrid)

Company: Stryker Group
Location: Portage
Posted on: March 19, 2023

Job Description:

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 withotherincredibly talented and intelligentpeople, 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: 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 Our benefitsinclude 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. Job Description Summary: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.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:Technical Responsibilities:--- Lead or mentor design and development of electrical components, sub-systems, and/or systems for medical devices--- Apply and mentor others on advanced engineering theories, principles, and concepts--- Conduct, design, and select advanced prototyping and testing--- Lead and guide in correction of complex product design issues--- Conduct technology exploration and influence application in the business--- Translate user needs to design inputs/ specifications and produce complex system level designs independently--- Develop a number of invention disclosures, patents or trade secrets--- Independently make design tradeoff decisions while designing multiple components of the systemBusiness Responsibilities:--- Contribute to competitive and market strategy by demonstrating in-depth knowledge of the market, customer dynamics and competitive offerings--- Apply strong understanding of clinical procedures to enhance product development--- Contribute to and execute customer facing activities like voice of customer and customer centric design in partnership with internal and external stakeholders--- Demonstrates financial acumen.Med Device Compliance:--- Mentor others as a business unit expert on the usage of industry standards, including design requirements and test strategies per applicable regulations--- Lead others to create and refine engineering documentation, such as the Design History file and creates more progressive technical content--- Contribute to R&D procedures and development of industry standards working closely with cross-functional business unitsGeneral Responsibilities:--- Work cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success, both leading and influencing other leaders on the team--- Identify and lead the creation of or improvements to procedures, policies, processes, systems, and technology required--- Execute and lead segments of complex product development to advance projects through the design /development/launch process--- Contribute to complex product development through release and lead one technical area of expertise--- Hold self and others accountable to deliver high quality results with passion, energy and drive to meet business priorities--- Mentor, develop and inspire others in current and future rolesMinimum Qualifications (Required):--- 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 of engineering experiencePreferred Qualifications (Strongly desired):Technical Skills:---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

Keywords: Stryker Group, Gary , Senior Staff Product Safety Engineer (Hybrid), Engineering , Portage, Indiana