Senior Staff Engineer, Product Safety in Portage, MI at Stryker Corporation

Date Posted: 3/28/2020

Job Snapshot

Job Description

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.
Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions. 
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices. 
 

As a Sr Staff Engineer in Product Safety, you will work as a development partner with the product design & development teams and evaluate new products & existing product modifications to the applicable requirements of safety standards as pertinent for the design of medical equipment and medical sterilization equipment.

What you will do

  • Partner with Product Development teams on design, development & sustainment of medical and sterilization devices to ensure the technical understanding of the required safety standards on the global scale.
  • Lead design analysis to support engineering teams within the boundaries of safety standards. Assist in identification, analysis, implementation of design elements and control of conditions impeding product safety.
  • Understand and interpret IEC60601-1 (Medical Electrical Product Safety), IEC61010-1 (Safety for electrical equipment for measurement, control, and laboratory use) and related standards. Strive for and become a Subject Matter Expert in applying safety regulations for product development.
  • Define and maintain the process for testing and certification of Sterilization equipment.
  • Conduct, coordinate and evaluate test results for safety testing, including EMI/EMC and Wireless.
  • Drive safety design reviews, participate in root cause analysis and implement appropriate actions.
  • Work with Product Development teams to define and develop any required test tools and fixtures in support of product safety testing and certification.
  • Serve as an interface between development teams and NRTLs (e.g. CSA, UL, ETL, TUV), other regulatory agencies.
  • Support Stryker's International Initiatives and work with Regulatory to launch products in Global Markets (such as Asia-Pacific, European Union and South America).
  • Support patient safety/clinical evaluations in collaboration with Sales and Marketing teams
  • Maintain proficiency of worldwide safety regulations via research, networking and ongoing education.
  • Provide support during regulatory audits, as needed.
  • Provide support to external test houses during product evaluations.
  • Create and maintain appropriate reports and related documents.
  • Collaborate with other divisions, partner with R&D, other product development resources and external contractors locally and globally.
  • Collaborate with other Product Safety engineers & with global R&D teams to support product portfolio

What you need

  • 6+ years of experience in Electrical or Bio-Electrical engineering, Product Safety/Compliance or similar.
  • Highly organized and capable of tracking multiple projects through various stages of development, while maintaining day-to-day oversight of compliance to regulatory standards for existing products.
  • Experience with medical devices is very beneficial
  • Working knowledge of regulations and standards related to Medical products (IEC60601) and products governed by IEC61010 is desirable
  • Understanding of sterilization processes and methodologies for the medical equipment is a plus
  • Being a resourceful, hands-on, problem solving individual with initiative and drive to get things done.
  • Strong technical leadership, communication, planning & organization skills with great work ethic.
  • Experience in supporting internal and external audits is helpful.
  • Currently active CSA, UL or ETL certification is a plus
  • Good interpersonal communication skills.
  • Excellent analytical skills.
  • Demonstrated mechanical/electrical problem solving skills.

Education/Special Training Required

  • B.S. in Electrical Engineering, Biomedical Engineering, or related curriculum.

Work From Home: Not available

Travel Percentage: 10%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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