Risk Management Engineer, Design QA — EU MDR Contract

Intellectt Inc; Mansfield (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical technology company is seeking a Risk Management Engineer to support Design Quality Assurance and EU MDR remediation initiatives. The ideal candidate will collaborate cross-functionally to ensure compliance with standards, develop and remediate risk management and usability documentation, and engage in continuous improvement of risk management processes. Candidates should have 5–7 years of experience in the medical device industry and strong knowledge of ISO 14971 and usability engineering. This is a contract role based in Massachusetts.

Qualifications

• 5–7 years of experience in medical device industry risk management.
• Strong expertise in ISO 14971 and usability engineering standards.
• Self-driven, hands-on engineer focused on execution.

Responsibilities

• Perform gap assessments of risk management files against standards.
• Develop and remediate risk management and usability engineering documentation.
• Drive continuous improvement in risk management processes.

Skills

ISO 14971

Usability engineering

Statistical methods

Risk management

Problem-solving

Education

Bachelor’s degree in Engineering

Job description

A leading medical technology company is seeking a Risk Management Engineer to support Design Quality Assurance and EU MDR remediation initiatives. The ideal candidate will collaborate cross-functionally to ensure compliance with standards, develop and remediate risk management and usability documentation, and engage in continuous improvement of risk management processes. Candidates should have 5–7 years of experience in the medical device industry and strong knowledge of ISO 14971 and usability engineering. This is a contract role based in Massachusetts.