Head Research and Development -Product Based Company

Job Description Head R&D / Product Development

Industry: Medical Devices / MedTech
Location: Bengaluru
Experience: 10+ years
Function: R&D / Product Development

Role Purpose

We are looking for an experienced Head R&D / Product Development to lead the company's medical-device product development function. The role will be responsible for driving the complete product development lifecycle from concept, feasibility and design through prototype development, testing, validation, regulatory documentation, product launch and design transfer to manufacturing.

The ideal candidate should have strong hands-on experience in medical-device product development and the ability to work effectively in a growing, entrepreneurial organisation.

Key Responsibilities

1. R&D Strategy & Product Development

• Develop and execute the R&D and product development roadmap aligned with business objectives.
• Identify opportunities for new products, product enhancements and technology upgrades.
• Translate customer/clinical requirements into product specifications and development plans.
• Lead concept development, feasibility studies, prototyping and product engineering.
• Manage multiple R&D projects and ensure delivery within agreed timelines, cost and quality parameters.

2. Design & Development

• Lead end-to-end medical-device design and development activities.
• Ensure appropriate design inputs, design outputs, design reviews, verification and validation.
• Review engineering drawings, specifications, BOMs, prototypes and technical documentation.
• Drive Design for Manufacturing (DFM), reliability, cost optimisation and product improvements.
• Manage engineering changes and product modifications through a controlled process.

3. Quality & Regulatory

• Ensure R&D activities comply with ISO 13485, CDSCO requirements and applicable medical-device standards.
• Work closely with QA/RA on regulatory strategy, technical documentation and product approvals.
• Ensure effective risk-management practices during product development.
• Support audits, regulatory submissions, certifications and compliance activities.

4. Testing, Validation & Industrialisation

• Define and drive product verification, validation, performance, safety and reliability testing.
• Coordinate with external laboratories and testing agencies wherever required.
• Lead design transfer from R&D to manufacturing and ensure product manufacturability.
• Support pilot production, supplier development and resolution of technical manufacturing issues.

5. Product Sustenance & Improvement

• Lead technical investigation of product failures, customer complaints and field issues along with Quality/Service teams.
• Drive root-cause analysis, corrective actions and product improvements.
• Identify opportunities for product cost reduction, value engineering and performance enhancement.
• Support the complete product lifecycle from launch to product upgrades/obsolescence.

6. Team Leadership

• Build, lead and mentor the R&D team and develop technical capabilities.
• Set clear objectives, KPIs and project priorities for the team.
• Foster a culture of innovation, ownership, documentation and problem-solving.
• Effectively manage external consultants, technology partners and testing agencies.

Candidate Profile

• B.E./B.Tech/M.E./M.Tech in Biomedical, Electronics, Instrumentation, Mechanical, Electrical, Mechatronics, Medical Electronics or related engineering discipline.
• 10–12 years of relevant experience, with at least 5 years in a leadership role.
• Strong experience in medical-device R&D / product development is mandatory.
• Proven experience in taking products from concept to prototype, verification/validation and commercialisation.
• Working knowledge of ISO 13485, CDSCO and relevant IEC/ISO standards.
• Experience in design controls, risk management, technical documentation and design transfer.
• Strong project management, problem-solving and cross-functional collaboration skills.
• Hands-on, innovative and commercially oriented approach.

Ideal Candidate: A hands-on R&D leader who has successfully developed and commercialised 2–3 or more medical-device products and can combine technical leadership, regulatory understanding, innovation and business orientation in a growing medical-device organisation.

IF interested kindly share your resume at [email protected] or give me a call at 9768928580