• Senior Staff Product Safety Lab Engineer

    Stryker (Portage, MI)


    The Senior Staff Product Safety Lab Engineer is responsible for leading and managing the Product Safety Lab, as well as being the resident technical expert for Product Safety Engineers in standards-based testing and lab technical development. This individual will also be responsible for technical training of Product Safety Engineers, lab technician(s) and establishing technical direction within the product safety lab. Lead, maintain and grow product safety lab by contributing safety test for successful certification of products.

     

    Check out our Instruments product portfolios: Stryker Neurosurgical (https://www.stryker.com/us/en/portfolios/medical-surgical-equipment/power-tools-and-cutting-accessories/neuro-and-spine.html)

     

    Stryker Surgical Technologies

     

    Stryker Orthopaedic Instruments (https://www.stryker.com/us/en/portfolios/medical-surgical-equipment/power-tools-and-cutting-accessories.html)

     

    This role is hybrid with 4+ days a week on-site in Portage, MI, due to the testing nature of the position.

    What you will do:

    + Responsible for any equipment, processes, accreditation, documentation, or audits associated with internal certification, preliminary and final product safety testing. Leads the design teams in analyzing acquired data and failures in order to provide actionable information to help improve design quality and efficiency with respect to compliance.

    + Possesses and applies an in-depth technical knowledge of principles, practices, and procedures for product design conformance to US and international electrical and mechanical safety standards, regulations, and initiatives. Provide detailed 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, and 3rd party labs with respect to our product safety testing.

    + Development and execution of detailed test plans with design, quality, and test teams. Works with Design Engineers to ensure the correct test processes and procedures are followed to gain and maintain product compliance.

    + Develop lab process and metrics to support business needs. Maintain lab CTF program with respective NRTLs.

    + Lead, guide the teams and serve as the testing expert for R&D and Product Safety team members, third party labs, lab technicians as necessary. Supports all of the above during engineering work, providing each group with the information necessary to drive product compliance with the applicable standards.

    + Lead teams for product safety compliance related issues effecting new product development or existing product engineering.

    + Work in ambiguous situations and bring in solutions for ambiguity.

    + Lead, train and provide guidance lab technician(s) for all safety related test executions.

    What you need:

    Minimum Qualifications:

    + Bachelor's Degree in Electrical Engineering, Computer Engineering, Systems Engineering Biomedical, Mechanical, or a related Engineering degree from an accredited college or university.

    + 6+ years engineering experience

    + 4+ engineering experience in product safety testing.

    Preferred Qualifications:

    + Possess an understanding of IEC standards and an understanding of compliance or related regulatory compliance standards.

    + 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 (Knowledge of General Requirements For The Competence Of Testing And Calibration Laboratories)

     

    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.