Medical Device R&D Process & Product Design Associate

Key Skills: ISO 13485, ISO 14971, IEC 62304, 21 CFR, Design Controls, Risk Management, Traceability Matrix, Medical Device Regulations

Roles & Responsibilities:

• Support post-production risk review activities as per defined regulatory schedules
• Coordinate with stakeholders to collect and analyze post-production data for risk assessment
• Prepare and update risk management reports and ensure approval workflow compliance
• Maintain traceability matrices linking design requirements to objective evidence
• Assist design control engineers in documentation and data analysis tasks
• Query internal/external databases and generate reports for R&D and risk teams
• Ensure documentation compliance with medical device regulatory standards
• Support lifecycle documentation across design, development, and post-production phases

Experience Required:

• 3-5 years of experience in medical device R&D, risk management, or design control processes
• Experience working in regulated environments (medical device or healthcare products)
• Exposure to post-production risk analysis and reporting activities
• Experience maintaining traceability matrices and design documentation
• Experience working with cross-functional R&D and quality/regulatory teams
• Experience supporting ISO 13485 / ISO 14971 compliance activities
• Experience in data analysis and reporting for engineering/R&D functions
• Exposure to IEC 62304 or similar medical software lifecycle standards is preferred
• Experience working with requirement management or documentation tools is an advantage

Education: Any Graduation