Risk Management Engineer; Design Quality Assurance

Risk Management Engineer (Design Quality Assurance)

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Direct message the job poster from Intellectt Inc

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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