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

Date Posted: 10/11/2019

Job Snapshot

Job Description

Work as development partner with the product engineering and product development groups and evaluate new products & existing product modifications to the applicable requirements of safety standards as pertinent for the design of medical equipment.

  • Work as development partner with the product engineering and product development groups and evaluate new products & existing product modifications to the applicable requirements of safety standards as pertinent for the design of medical equipment.
  • Work with Product Engineering and Operations teams to ensure compliance to global product safety requirements.
  • Partner with Product Development teams on design, development & sustainment of medical devices to ensure the technical understanding of the required safety standards on the global scale.
  • Carry out design analysis to support engineering teams within the boundaries of safety standards. Assist in identification, analysis, and control of conditions impeding product safety.
  • The Ability to understand and interpret IEC60601-1 (Medical Electrical Product Safety) and related standards.
  • Support change management and product sustainment activities.
  • Create and maintain appropriate reports and related documents.
  • Conduct and/or coordinate safety testing, including EMI/EMC and Wireless Compliance, on existing and new products, and evaluate test results.
  • Drive safety design reviews participate in root cause analysis and implement appropriate actions.
  • Serve as interface between development teams and CSA, UL, ETL, TUV and other regulatory agencies.
  • Provide support to external test houses during product evaluations.
  • 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.
  • Obtain certification (typically through on-the-job training) to perform required testing to IEC 60601 series standards (Medical Electrical Equipment Safety), IEC 62133 (Lithium Ion Battery Safety) and others, as needed.
  • Provide support during regulatory audits, as needed.

Minimum Qualifications

  • 6+ years of relevant experience in Product Safety, Compliance, Electrical or Bio-electrical engineering
  • Experience with medical devices is very beneficial
  • Working knowledge of CSA, EN, IEC and other regulations and standards relating to Medical (60601) products is desired
  • Being 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.
  • Excellent analytical skills.
  • Demonstrated mechanical/electrical problem solving skills.
  • Strong technical leadership, communication, planning & organization skills with great work ethic.
  • Being a resourceful, hands-on, problem solving individual with initiative and drive to work around administrative and technical obstacles.
  • Experience in supporting internal and external audits is helpful.
  • Currently active CSA, UL or ETL certification is a plus
  • Good interpersonal communication skills.

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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