Why the need:
- One existing resource is overloaded. Supporting MDR program for infusion pump remediation for MDR submission
Experience Required:
- Electromechanical Medical Device background, Infusion pumps is preferred
- 5+ years of experience with 60601, 62304, 62366, 62133, 14971.
- 60601-2-24 experience is a plus
- Experience with MDR
- Experience coordinating and implementing product testing at external test laboratories
- Experience with identifying requirements for compliance test plan
- Background in Electrical/Electronic or Mechanical preferred.
CH: Compliance Engineer (235101)
#LI-Onsite