Senior Design Quality Engineer - MedTech Robotics

The Mullings Group; Boston (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

The Mullings Group is searching for a Design Quality Engineer for Swan EndoSurgical in Boston, MA. This role focuses on developing and improving quality management systems in compliance with ISO 13485.

The ideal candidate will have 4 to 7 years of experience in the medical device industry and a strong understanding of risk management and design controls. This opportunity offers minimal travel and a fast-paced environment.

Qualifications

• 4 to 7 years of medical device experience with a BS.
• 3 to 6 years of experience with an MS.
• Working knowledge of ISO 13485 and FDA 21 CFR Part 820.

Responsibilities

• Develop and improve the QMS in compliance with ISO 13485.
• Embed quality requirements into design and development.
• Conduct risk management activities like hazard analysis.

Skills

ISO 13485

FDA 21 CFR Part 820

Risk management

Design control

Experience with eQMS platforms

Education

Bachelor's or Master's in Engineering or Biomedical Engineering

Tools

Requirements management tools

Job description

The Mullings Group is searching for a Design Quality Engineer for Swan EndoSurgical in Boston, MA. This role focuses on developing and improving quality management systems in compliance with ISO 13485.

The ideal candidate will have 4 to 7 years of experience in the medical device industry and a strong understanding of risk management and design controls. This opportunity offers minimal travel and a fast-paced environment.