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