Intellectt Inc
Website:
intellectt.com
Job details:
Industry: Medical Devices
Job Title: Risk Management Engineer
Location: Remote
Experience: 10+ Years
Job Overview:
We are seeking an experienced Risk Management Engineer to support design remediation and risk management activities for medical device products. The ideal candidate will have extensive experience in medical device risk management, design controls, and regulatory compliance, with a strong understanding of ISO 14971, FDA QMSR, and applicable global regulatory standards.
Key Responsibilities:
- Provide risk management expertise across product remediation and design-control workstreams.
- Review design documentation to ensure appropriate identification, evaluation, and mitigation of product risks.
- Support retrospective design reviews and documentation remediation activities.
- Develop risk-based justifications to address documentation gaps.
- Update and maintain Risk Management Files, Hazard Analyses, Risk Assessments, and Risk Control documentation.
- Ensure risk controls are properly implemented, verified, and traceable to design requirements and verification activities.
- Review User Needs, Design Inputs, Design Outputs, Verification & Validation (V&V), and Design Transfer documentation from a risk management perspective.
- Identify risk management gaps and recommend corrective actions.
- Collaborate with Engineering, Quality, Regulatory Affairs, Clinical, Manufacturing, and Validation teams throughout remediation activities.
- Ensure compliance with FDA Quality Management System Regulation (QMSR), ISO 14971, and other applicable regulatory requirements.
- Support internal audits, regulatory inspections, and remediation programs.
Required Qualifications:
- Bachelor's or Master's degree in Engineering or a related technical discipline.
- 10+ years of experience in Medical Device Risk Management.
- Hands-on experience supporting Design Controls and Remediation Programs.
- Strong working knowledge of ISO 14971 and FDA QMSR requirements.
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