Research And Development Specialist

Job Title: Senior Executive R&D (Medical Devices)

Department: Research & Development

Reporting To: Associate Manager

Role 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 audits

Key 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 coordination

Qualification: Bachelor's or master's degree in: Biomedical / Mechanical / Polymer / Materials / Life Sciences or related field.

Experience

• 24 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 preferred

Performance 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