Risk Management Engineer

About Intellectt

Intellectt stands at the forefront of blending emerging technologies, deep domain knowledge, and innovation to deliver superior engineering, IT, and consulting services. With a rapidly expanding presence in the US technology services sector, Intellectt specializes in industries such as manufacturing, medical devices, healthcare, banking, and financial services, empowered by capabilities in AI, NLP, Blockchain, Cloud, and more. This enables clients to successfully adapt and thrive amidst complex technological and business challenges.

Role Overview

The Risk Management Engineer will play a crucial role in supporting remediation efforts by ensuring thorough risk assessment and management during retrospective design reviews and updates to documentation. The position emphasizes compliance and alignment with FDA Quality Management System Regulation and ISO 14971 risk management expectations.

Key Responsibilities

• Offer expert guidance on risk management across multiple remediation workstreams.
• Analyze design documentation to verify adequate incorporation of product risk considerations.
• Assist in retrospective evaluation of risk within existing design documentation.
• Contribute to developing risk-based reasoning where documentation is incomplete.
• Ensure that risk factors are integrated during documentation updates and remediation processes.
• Advise on adherence to risk management standards per FDA QMSR and ISO 14971.
• Work closely with cross-departmental teams to embed risk perspectives effectively.
• Evaluate user needs, product requirements, design inputs and outputs, V&V documentation, and design-transfer records for risk implications.
• Support updates to risk management files including hazard analyses, risk assessments, and traceability of risk controls.
• Detect risk management deficiencies and suggest correctional actions.
• Confirm that risk control measures are properly validated and linked to relevant design and testing documentation.
• Assist with regulatory inspections, audits, and remediation programs.

Required Qualifications

• Over 10 years' experience in risk management within medical device product development.
• Proven background supporting remediation initiatives in highly regulated environments.
• Solid grasp of risk management principles and methodologies.
• Experience applying or assessing risk management processes aligned with ISO 14971 standards.
• Knowledge of FDA QMSR and global regulatory risk management requirements.
• Capable of critically reviewing design documentation with an emphasis on risk assessment.
• Expertise in hazard analysis, risk evaluation, implementation of risk controls, and residual risk assessment.
• Excellent skills in technical writing and documentation review.
• Ability to collaborate effectively with Engineering, Quality, Regulatory, Clinical, Manufacturing, and Verification & Validation teams.

Preferred Qualifications

• Proficiency with FMEA, FTA, use-related risk analysis, and benefit-risk assessment techniques.
• Experience in remediating Design Controls.
• Competence in creating traceability among hazards, risk controls, design requirements, and verification steps.
• Familiarity with ISO 13485, IEC 62304, IEC 62366, and other medical device standards.
• History of supporting FDA inspections or Notified Body audits.