Senior Designs Assurance Quality Engineer

Manage Design Control and product design and change Risk Management processes for sterile catheter-, software-, electromechanical-based medical device product families.

Requirements

• BS in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline
• 5-8 years of design assurance experience in medical device design and manufacturing environment
• Proven track record of completing new product introduction transfers to Operations
• Working knowledge of Medical Device Regulation FDA 21 CFR 820 and ISO 14971, 13485, ISO 10993, IEC 60601 and IEC 62304 series of standards
• Experience with preparing and reviewing design documentation in support of regulatory submissions
• Working knowledge of data analysis methods, including basic statistics
• Working knowledge with various quality tools such as Failure Mode and Effects Analysis (FMEA) and Use Related Risk Analysis (URRA)
• Experience with manufacturing complex medical devices, including process validation and equipment qualification requirements (IQ/OQ/PQ).
• Experience managing third-party development and test organizations.

Benefits

• Commensurate salary