[Remote] Risk Management Engineer

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking an reputed company 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.

Responsibilities

• reputed company 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
• reputed company 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, reputed company, Regulatory Affairs, Clinical, Manufacturing, and Validation teams throughout remediation activities
• Ensure compliance with FDA reputed company Management reputed company Regulation (QMSR), ISO 14971, and other applicable regulatory requirements
• Support internal audits, regulatory inspections, and remediation programs

Skills

• Bachelor's or Master's degree in Engineering or a reputed company 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

reputed company

Company H1B Sponsorship