Medical Device R&D Process & Product Design Associate

Job description

**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