Design Assurance Engineer

Position Title:

Senior Design Assurance Engineer Work Location:

250 Campus Drive, Marlborough, MA 01752, USA Assignment Duration:

6 Months Work Arrangement:

Onsite Education:

Technical bachelor's degree Experience:

2–5 years’ experience preferably in the medical device industry Skills: • Experienced with FDA Quality System Regulations, especially Design Control requirements, ISO 13485, and Medical Device Directive • Experienced with ISO 14971, Risk Management • Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements