Risk Management Engineer (Design Quality Assurance)

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

Risk Management Engineer (Design Quality Assurance)

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Talent Acquisition Lead at Intellectt Inc | MBA, Global Talent Acquisition

Job Summary:

We are seeking a hands‑on Risk Management Engineer to support Design Quality Assurance and EU MDR remediation initiatives. This role requires an engineer who can actively develop, remediate, and execute risk management and usability documentation—not a consulting role. The ideal candidate will collaborate cross‑functionally to ensure compliance with EU MDR and applicable standards.

Key Responsibilities:

• Perform gap assessments of risk management and usability files against EU MDR and relevant standards (ISO 14971, IEC 62366)
• Develop and remediate risk management and usability engineering documentation
• Lead protocol development and apply statistical methods to risk evaluation
• Support post‑market surveillance through Health Impact Assessments and Hazard Evaluations
• Drive continuous improvement in risk management processes and metrics

Qualifications:

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, or related)
• 5–7 years of medical device industry experience in Risk Management
• Strong expertise in ISO 14971 and usability engineering standards
• Working knowledge of statistical methods applied to risk analysis
• Self‑driven, hands‑on engineer focused on execution and problem‑solving

Seniority level: Mid‑Senior level

Employment type: Contract

Job function: Engineering and Quality Assurance
Industries: Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing

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