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Sr. Product Safety Engineer

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Stevensville, MI
$70,000 - $120,000
Job Type
Direct Hire
Bachelor of Science
Jan 10, 2019
Job ID
Sr. Product Safety Engineer
Stevensville, MI

Job Summary of the Sr. Product Safety Engineer:
Sr. Level Product Safety Engineer is required to play a vital role in supporting safety evaluations and in ensuring compliance with global safety requirements for one of our clients in the Michigan. This client is a global player in the field of advanced medical devices and healthcare technology. In this role, you will be responsible for performing  design analysis to support the development of products as per the safety standards along with this you will also ensure safety compliance by conducting and coordinating the safety tests on the products. If you have a good experience in Product Safety, Compliance, Electrical or Bio-electrical engineering, then this position is well suited to you. 
You will be part of a 10 person engineering department with access to state of the art test equipment/chambers etc. and have the opportunity to get you hands on the technology by doing test set-up and validation. This is a fast paced environment with a lot of opportunity to learn and grow.  You will be acting like an internal consultant to make sure the rest of the development is in compliance with product safety.  
This is a good opportunity to transfer your skills from other industries and become part of the medical industry, for example in addition to Aerospace Product Safety Engineers, Functional Safety Engineers from Automotive are a very good fit.  

Responsibilities of the Sr. Product Safety Engineer:
  • Work with the product development team for product evaluation and modifications as per the requirements of safety standards in the Medical device industry.
  • Learn about, understand and interpret IEC60601-1 (Medical Product Safety ) and related standards and support change management and product sustainment activities
  • Conduct root cause and design analyses to resolve product issues and to support product development as per the safety standards
  • Conduct and coordinate safety testing, including EMI/EMC and Wireless Compliance to ensure safety compliance according to IEC 60601-1-2, and evaluate test results
  • Collaborate with external test houses, outside agencies, and external manufacturing locations during product evaluations and regulatory audits.
  • Ensure compliance with global safety requirements by providing consultation for R&D, Operations and other cross-functional divisions.
  • Perform safety design reviews with the project teams and assist in identification, analysis, and control of conditions impeding product safety
  • Work with Regulatory to launch products in Global Markets such as Asia-Pacific, European Union, and South America.
  • Collaborate with R&D, other product development resources and external contractors locally and globally
  • Liaison 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.
  • Create and maintain appropriate reports and related documents.?
  • Obtain certification to perform required testing to IEC 60601 series standards (Medical Electrical Equipment Safety), IEC 62133 (Lithium Ion Battery Safety) and others

Qualifications of the Sr. Product Safety Engineer:
  • BS in Electrical or Biomedical Engineering with Electrical Engineering concentration, or related curriculum.
  • Experience in Product Safety, functional safety or compliance
  • Practical knowledge of CSA, EN, IEC and other regulations and standards relating to Medical (60601) products is desired
  • Skilled in technical leadership, communication, planning & organization, analytics and mechanical/electrical problem solving
  • Experience in supporting internal and external audits is helpful.
  • Experience with medical devices is very beneficial
  • Active CSA, UL or ETL certification is a plus
  • Capability of tracking multiple projects through various stages of development
  • Capability to maintain day-to-day oversight of compliance to regulatory standards for existing and new products

Compensation of the Sr. Product Safety Engineer:
Salary Range:  $70,000-$120,000/year, depending on experience

Location: Stevensville, MI
Type:  Limites
Travel:  None
Relocation Assistance:  Yes
Visa Sponsorship:  H1B transfers only. NO OPT/F1 will be considered

Knowledge of the following areas may be helpful:- Electrical, Safety, R&D , Operations, compliance, standards,  medical,  IEC60601-1, analysis, "change management ", EMI, EMC, "Wireless Compliance ", "IEC 60601-1-2 ", "root cause", evaluation, audit, Regulatory, "Medical Electrical Equipment Safety ", "IEC 62133 ", "Lithium Ion Battery Safety ", Biomedical?, CSA, EN, IEC?, CSA, UL, ETL, ISO 26262