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Design Compliance Engineer
1 month ago
- Location: (ONSITE or REMOTE) - Skaneateles, NY (13153)
- Duration: 5 months - End Date: 12/31/2025 (Contract extension expectation)
- Type: W2 contract (NO C2C OR THIRD PARTY)
- Shift: 1st shift
- Pay: Negotiable depending on related direct experience
Job Summary:
- Work with NPD and Sustaining teams to realize compliant products based on national and international codes. Determine applicable standards and interpret them for new and current products.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- 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,
ISO10535 and EN 60601-2-52
- Detailed knowledge of 60601-1-2 preferred
EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS:
- BS Degree in Electrical or Mechanical Engineering or equivalent experience.
- Previous Design Compliance Experience.
- Minimum of 5 years' experience in the medical device industry.
- Minimum of 5 years' experience in Compliance Engineering equivalent in working with Notified Bodies and standards preferred.
- Excellent written and oral communication skills.
- Self-motivated with high performance standards.
Work Authorization:
- Must be able to work in the United States with current employment authorization documents. Visa status that requires sponsorship now or in the future is not allowed for this role. Visa sponsorship is not available, now or in the future, for this position.
Important information: To be immediately considered, please send an updated version of your resume to Deas172@ -
*** (Kelly does not expense relocation/interview costs)**
In addition to working with the world's most recognized and trusted name in staffing, Kelly employees can expect:
- Competitive pay
- Paid holidays
- Year-end bonus program
- Recognition and incentive programs
- Access to continuing education via the Kelly Learning Center
