Resolve compliance issues by working with various engineering disciplines such as electrical, mechanical, and software.
Define compliance strategies to certify and list products.
Provide technical review of product to ensure alignment with national and international codes.
Help maintain and sustain the product technical files for the production life of the products.
Assist product development teams in applying and understanding design standards and codes.
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.
Experience working in a regulated industry.
Experience working in the codes and standards capacity at a Medical Device manufacturer, or hospital electrical and medical gas supplier.
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).
Knowledge of lEC based safety standards, preferred: IEC/EN/UL 60601-1, lEC 60601-11, and EN 60601-2-52
Maintain necessary technical and certification files for agency review and approval, as needed.
May have some supervisory responsibilities as required based on projects
Ability to perform all assigned tasks, work independently, and complete work on schedule
Ability to communicate effectively in multi-discipline, cross cultural environment and levels of organization
Strong problem solving skills and efficient management of time and resources