Device Development Manager

Biocon Biologics; Bengaluru; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Biocon Biologics Limited in Bengaluru seeks a Senior Lead to drive the development of drug delivery devices and combination products. You will provide technical leadership for device design, design controls, risk management, verification, validation, commercialization, and lifecycle management, guiding a team of device engineers and scientists.

You will collaborate across R&D, Regulatory, Quality, Manufacturing, and Supply Chain to deliver robust, compliant products and drive strategic device

Qualifications

• 10+ years in medical devices or drug-device combinations.
• Proven experience leading technical teams and people management.
• Experience developing/commercializing regulated medical devices or combination products.
• Strong leadership and cross-functional influence.

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.
• 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 across the lifecycle, including risk management and design transfer.
• Lead product risk management using ISO 14971, including risk assessments and FMEAs.

Skills

People leadership

Stakeholder management

Risk-based decision making

Communication

Execution

Influence across functions

Education

Bachelor's or Master's in Engineering/Biomedical Engineering or related

Tools

Design Controls

ISO 14971

Quality Systems

Job description

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.
• 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
• Primary container and device integration
• 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.