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Job Title: Senior Executive – R&D (Medical Devices)Department: Research & DevelopmentReporting To: Associate ManagerRole Summary: Responsible for executing medical device design and development activities in compliance with EN ISO 13485, ISO 14971, and applicable regulatory requirements. Supports design controls, testing, risk management, and technical documentation.Key Responsibilities:- Execute product design, prototyping, and feasibility activities - Prepare and maintain design documents (DHF, protocols, reports) - Support design controls (inputs, outputs, reviews, V&V) - Conduct bench and functional testing - Support risk management (hazard analysis, FMEA, controls) - Coordinate with QA/RA, manufacturing, and suppliers - Support MDR/FDA technical documentation - Assist in change management and design transfers - Support internal and external auditsKey Skills- Knowledge of ISO 13485, ISO 14971, MDR, FDA QSR - Hands-on testing and documentation skills - Strong analytical and problem-solving ability - Good technical writing and compliance mindset - Cross-functional coordinationQualification: Bachelor's or master's degree in: Biomedical / Mechanical / Polymer / Materials / Life Sciences or related field.Experience- 2–4 years in Medical Device R&D or regulated industry - Experience with design documentation, V&V testing, and risk management - Exposure to cardiovascular/implantable devices is preferredPerformance Indicators (KPIs)- Timely completion of design and test documentation - Compliance with design control requirements - Quality and accuracy of reports and protocols - Audit readiness of assigned projects - Effective cross-functional coordination