The Compliance Engineer will work with New Product Development (NPD) and Sustaining teams to ensure products comply with national and international codes and standards. This role involves determining applicable standards, interpreting them for both new and existing products, and resolving compliance issues across various engineering disciplines.
Essential Duties And Responsibilities
Collaborate with electrical, mechanical, and software engineering teams to resolve compliance issues.
Define and implement compliance strategies to certify and list products.
Conduct technical reviews of products to ensure alignment with national and international codes.
Maintain and update product technical files throughout the product lifecycle.
Assist product development teams in understanding and applying design standards and codes.
Submit compliance reports to safety agencies and review third-party technical files and documentation.
Ensure user documentation includes required warnings, labels, and symbols as per standards.
Required Qualifications & Experience
BS Degree in Electrical or Mechanical Engineering or equivalent experience.
Minimum of 5 years in the medical device industry.
Minimum of 5 years in Compliance Engineering, working with Notified Bodies and standards.
Required Skills
Strong knowledge of IEC-based safety standards, including but not limited to IEC/EN/UL 60601-1, IEC 60601-11, ISO 10535, and EN 60601-2-52.
Familiarity with IEC 60601-1-2 is preferred.
Proven ability to assess the application of codes and standards to new product designs to obtain and maintain agency certifications (e.g., UL, IEC, VDE, CSA).
Experience in a regulated industry, particularly in medical device manufacturing or hospital electrical and medical gas supply.
Excellent written and oral communication skills.
Self-motivated with high performance standards.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Management and Manufacturing
Industries
Medical Equipment Manufacturing
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