Sr. Electrical Engineer, Product Safety (Medical Device)

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Location
MI
Job Type
Direct Hire
Date
Nov 26, 2018
Job ID
2633908
Employment Type: Permanent, Full-Time
Location: Southern Michigan
Job Description:
The Product Safety Engineer will plan/implement the design, manufacture, installation and/or maintenance of electrical systems and apparatus, such as electric motors, machinery controls, lighting, wiring and power systems/devices, for the generation, transmission and control of electric power.

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Additionally, the role will provide consultation to product development groups and evaluate new products & existing product modifications to the applicable requirements of safety standards as applicable for the design of medical equipment.

Responsibilities Include

 
  • Provide consultation for R&D and Operations to ensure compliance to global safety requirements.
  • Assist product development teams with the technical understanding of the required safety standards during the design & development of medical devices.
  • Understand and interpret IEC60601-1 (Medical Product Safety ) and related standards.
  • Carry out design analysis to support the development of products within the boundaries of safety standards. Assist in identification, analysis, and control of conditions impeding product safety.
  • Support change management and product sustainment activities.
  • Conduct and coordinate safety testing, including EMI/EMC and Wireless Compliance, on existing and new products to ensure safety compliance according to IEC 60601-1-2, and evaluate test results.
  • Conduct root cause analysis and implement due diligence actions to resolve product issues.
  • Drive safety design reviews with the project teams
  • Provide support to external test houses during product evaluations.
  • Interact with outside agencies during regulatory audits, as needed.
  • Interact with external manufacturing locations during agency audits, as needed.
  • Collaborate with other divisions to ensure safety compliance. Partner with R&D, other product development resources and external contractors locally and globally.
  • Support International Initiatives and work with Regulatory to launch products in Global Markets (such as Asia-Pacific, European Union and South America).
  • Serve as a direct interface and facilitator between internal development teams and CSA, UL, ETL, TUV and other regulatory agencies.
  • Support patient safety/clinical evaluations in collaboration with Sales and Marketing teams
  • Maintain proficiency of worldwide safety regulations through research, development of network, and ongoing education.
  • Obtain certification to perform required testing to IEC 60601 series standards (Medical Electrical Equipment Safety), IEC 62133 (Lithium Ion Battery Safety) and others, as needed.
  • Create and maintain appropriate reports and related documents. 
     
Requirements:

 
  • B.S. in Electrical Engineering, Biomedical Engineering with Electrical Engineering concentration, or related curriculum.
  • 2-4 years 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.