Device Development Program Manager

Role : Device Development Program Manager

Location: Bangalore, India

Why Join Biocon Devices Team

Be part of a team developing innovative medical and drug-device solutions that directly improve patient lives. Gain exposure to end-to-end product development, collaborate with cross-functional experts, and grow your career in a dynamic, innovation-driven environment.

Position Summary :

Lead the development of drug delivery devices and combination products across Biocon's portfolio. Provide technical leadership for device design, design controls, risk management, verification, validation, commercialization, and lifecycle management while leading a team of device development engineers and scientists.

Key Responsibilities :

• Build, coach, and develop a high-performing device development team.
• Drive device integration with drug products and primary containers to deliver robust combination product solutions.
• Contribute to cross-functional teams across R&D, Regulatory, Quality, Clinical, Manufacturing, and Supply Chain to achieve program objectives.
• Lead end-to-end development of combination products, primary containers, and drug delivery devices.
• Manage external device partners and technology suppliers.
• Lead device development strategy, technical plans, and key design decisions.
• Ensure rigorous application of Design Controls, including User Needs, Design Inputs/Outputs, Risk Management, Verification, Validation, Human Factors, Design Transfer, and Change Control.
• Lead product risk management activities using ISO 14971 methodologies, including risk assessments, FMEAs, and risk-control verification.

Qualifications :

• Bachelor's or Master's degree in Engineering, Biomedical Engineering, or related discipline.
• 10+ years of experience in medical devices and/or drug-device combination products.
• Proven experience leading technical teams; prior people management experience is required.
• Demonstrated experience developing and supporting commercial regulated medical devices or combination products.

Leadership Competencies :

• Strong technical leadership
• Ability to influence and drive execution across functions
• Excellent communication and stakeholder management
• Strong problem-solving and risk-based decision making
• High ownership, accountability, and execution focus

Technical Expertise :

• Drug delivery devices and combination products
• Product design and development
• Design Controls and lifecycle management
• Design Verification & Validation
• Primary container and device integration
• Human Factors Engineering
• Risk Management (ISO 14971)
• Technology transfer and commercialization

Biocon is an Equal Opportunity Employer and is committed to building an inclusive workplace. We celebrate diversity and welcome applications from all qualified candidates regardless of race, religion, gender, sexual orientation, gender identity, age, disability, or any other legally protected characteristic.