Head of Medical Device Research & Development (R&D Centre Head)

The Head of Medical Device R&D is responsible for strategic leadership, innovation, product development, and regulatory-compliant execution of medical devices from concept to commercialization. This role leads multidisciplinary teams to deliver safe, effective, and commercially viable medical technologies aligned with clinical needs and business objectives.

Key Responsibilities

1. Strategic Leadership

• Define and execute the R&D roadmap aligned with corporate strategy and market needs
• Identify emerging technologies, clinical gaps, and innovation opportunities
• Build partnerships with clinicians, academic institutions, startups, and global collaborators

2. Product Development & Innovation

• Oversee end-to-end development of medical devices (Class IIII as applicable)
• Drive design control, usability engineering, risk management, and verification & validation
• Ensure application of Human Factors Engineering (IEC 62366)
• Promote design-for-manufacturability (DFM/DFA) and cost optimization

3. Regulatory & Quality Compliance

• Ensure compliance with:
• ISO 13485 (QMS)
• ISO 14971 (Risk Management)
• IEC 60601 / IEC 61010 (Electrical Safety, where applicable)
• FDA (21 CFR 820), CE MDR, CDSCO (India)
• Collaborate with Regulatory Affairs on submissions, audits, and certifications
• Maintain strong design history files (DHF), technical documentation, and traceability

4. Team Leadership & Capability Buildin

• Lead and mentor cross-functional teams:
• Hardware, software, firmware
• Mechanical design
• Clinical & biomedical engineering
• Quality & regulatory interfaces
• Recruit, develop, and retain high-performing R&D talent
• Foster a culture of innovation, quality, and accountability

5. Clinical & Stakeholder Engagement

• Work closely with clinicians, hospitals, and clinical research teams
• Translate clinical requirements into engineering specifications
• Support clinical evaluations, trials, and post-market surveillance feedback

6. Budget, IP & Portfolio Management

• Manage R&D budgets, timelines, and resource allocation
• Drive IP strategy: patents, freedom-to-operate, and innovation protection
• Track project KPIs, risk, and portfolio performance

7. Manufacturing & Commercialization Support

• Collaborate with Manufacturing, Supply Chain, and Marketing teams
• Support technology transfer, pilot builds, scale-up, and post-launch improvements
• Address field issues and continuous improvement initiatives

Required Qualifications

Education

• PhD / Masters in:
• Biomedical Engineering
• Electrical / Electronics / Mechanical Engineering
• Medical Physics or related field
• MBA or leadership certification is an advantage

Experience

• 15+ years in medical device R&D
• 5+ years in senior leadership or center-head role
• Proven track record of successful device commercialization
• Experience with regulated global markets (US/EU/India)

Technical Competencies

• Medical device design lifecycle
• Embedded systems / software (IEC 62304)
• Risk management & usability engineering
• Clinical validation & regulatory pathways
• Strong understanding of hospital workflows and clinical needs

Leadership & Soft Skills

• Visionary and strategic thinker
• Strong decision-making under regulatory constraints
• Excellent communication with clinicians, regulators, and executives
• Ability to lead large, multidisciplinary teams

Key Performance Indicators (KPIs)

• Product launch success rate
• Regulatory approval timelines
• R&D cost and schedule adherence
• IP generation (patents)
• Clinical adoption and market impact

Ideal Background (Preferred)

• Experience in diagnostics, imaging, patient monitoring, dialysis, implantable or digital health devices
• Prior exposure to hospital-driven innovation or clinician-scientist collaboration