Job Description :
Qualifications:
A Bachelor’s Degree in Electrical or Mechanical Engineering.
A minimum of 8 to 10 years of experience, having completed at least 10 submissions, 5 of which for new products
Working knowledge of the following industry regulations:
o IEC 60601-1 family of standards, including EMI/EMC requirements;
o IEC Standards 60950, 61010, and 62366;
o ISO 14971 for risk management; and
o EU Medical Device Directive 93/42/EEC.
Experience with FDA Class 1 and Class 2 medical devices.
Working knowledge of regulatory submission processes including FDA 510(k), Health Canada, and China SFDA.
Working knowledge of the RoHS directive, the WEEE directive, and Low Voltage directive.