About the Role
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 a product safety program plans for large, complex development programs for assigned business units within Stryker Instruments.
- 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 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.
- 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).
- Steer future technology roadmaps by participating in technology / methodology trade studies and research / development programs.
What You Need (Required Qualifications)
- Bachelor's Degree in Electrical Engineering, Biomedical Engineering or a related Engineering degree from an accredited college or university.
- 6+ years of relevant engineering experience.
Preferred Qualifications (Strongly Desired 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)
