Job Description

Description:

We are seeking a contract for Medical Product Compliance Engineer reporting to the Sr. Engineering Manager of Codes and Standards. Collaborate with both the New Product Development (NPD) and Sustaining teams to ensure that products developed and maintained comply with national and international standards.


What you will be doing
  • Provide technical review of products to ensure alignment with national and international safety and EMC standards.
  • Assist product development teams in applying and understanding design standards and codes.
  • Resolve compliance issues by working with various engineering disciplines such as electrical, mechanical, and software.
  • Understanding of risk analysis and how it relates to basic safety and essential performance.
  • Conducting gap assessments based on product changes.
  • General understanding of component level standards
  • Help maintain and sustain the product technical files for the life of the
  • Coordinate with agencies such as UL, TUV, Intertek, etc. to obtain product compliance reports and certifications.
  • Understanding of risk analysis and how it relates to basic safety and essential performance.
  • Develop product specific test plans to ensure the accuracy of the products and comply with country deviations.
  • Review 3rd party technical files and documentation.
  • As needed participate in standards committees.
What you bring
• Minimum of 5 years' experience in the medical device industry.
• BS Degree in Electrical or Mechanical Engineering or equivalent experience.
• Minimum of 5 years' experience in Compliance Engineering equivalent in working with Notified Bodies and standards preferred.
• Experience working in the codes and standards capacity at a Medical Device manufacturer
• Knowledge of medical safety standards
o preferred: IEC/EN/UL 60601-1, lEC 60601-1-11, and 60601-1-8.
• Demonstrated ability to assess the application of Codes & Standards to new product designs in order to obtain & maintain the agency certifications specified by the design requirements (e.g. UL, lEC, VDE, CSA).
• Experience in performing IEC 60601-X tests and test setups preferred.
• Experience or understanding of ISO 14971, FDA and EU requirements preferred.
• Experience or understanding of EMC preferred.
• Excellent written and oral communication skills.
• Self-motivated with high performance standards.

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