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USA - Engineer III

3 months ago

Skaneateles, United States LanceSoft Full time

Codes & Standards Engineer
Pay rate: $50 -$54/hr

Description
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.

This position can be located in Skaneateles Falls, NY

ESSENTIAL DUTIES AND RESPONSIBILITIES: - Other duties may be assigned:
• 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 60601-1-11, and 60601-1-8
• Detailed knowledge of 60601-1-2 preferred

Qualifications
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.

Job NPD

Primary Location Remote
Schedule Full-time
Shift 1st Shift