Codes and Standards Engineer

Confidential Company  •  Batesville, IN

8 - 10 years experience  •  Technology

Salary depends on experience
Posted on 05/26/18 by Cynet Sytems
Confidential Company
Batesville, IN
8 - 10 years experience
Technology
Salary depends on experience
Posted on 05/26/18 Cynet Sytems

Job Description:

  • Min 8+ year of exp

Details:

  • 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

SKILLS:

  • 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 

NOTE:

  • Medical

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