What you will be doing
• Provide technical review of product to ensure alignment with national and international standards.
• Assist product development teams in applying and understanding design standards and directives.
• Resolve compliance issues by working with various engineering disciplines such as electrical,
mechanical, and software.
• Help maintain and sustain the product technical files for the production life of the products.
• Submit required compliance reports to safety agencies and review 3rd party technical files and documentation.
• Review user documentation to ensure that required warnings, labels and symbols are properly
documented as required by standards.


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.