- Min 8+ year of exp
- Codes & Standards
- 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