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
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