Product Safety Engineer

Title: Codes & Standards Engineer

Location: Skaneateles Falls, NY (100% Onsite)

Duration: 12 months

Pay Rate: $50.00 - $55.00/hr on W2

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: - 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 60601-11, 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.