R&D Verification Validation Engineer

Biocon Biologics; Bengaluru; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Biocon Biologics Limited seeks an experienced Design Quality and Regulatory specialist to ensure medical device products meet global standards across design, verification, validation, and documentation.

You will collaborate with R&D, Manufacturing, Quality, and Regulatory teams, lead design control activities, manage risk, usability engineering, and inspections, contributing to product lifecycle excellence. Based in Bengaluru, this role offers exposure to international regulatory environments.

Qualifications

• Engineering graduate with 5–8 years of relevant industrial experience in medical devices.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and related standards.
• Experience in design control activities, risk management, usability engineering, and design verification/validation.
• Experience with regulatory audits and post-market surveillance.

Responsibilities

• Represent Design Quality on device projects and coordinate with R&D, Quality, Manufacturing, and Regulatory.
• Ensure changes and development comply with FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Contribute to design and manufacturing docs for verification, validation, and testing.
• Lead or support design verification, validation, usability engineering, and risk management.
• Apply statistical methods with risk-based justification.
• Compile Design History File / Technical File for regulatory audits.
• Support inspections and post-market surveillance.

Skills

Regulatory compliance

Quality systems

Design control

Risk management

Usability engineering

Cross-functional collaboration

Education

B.Tech / M.Tech in engineering

Job description

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 Summarry :

A highly specialized quality and compliance-focused role responsible for ensuring that medical device products are designed, developed, verified, and validated in accordance with global regulatory and quality standards. The incumbent partners closely with R&D, Manufacturing, Quality, and Regulatory teams to drive design control activities, risk management, usability engineering, and technical documentation throughout the product lifecycle.

Primary responsibilities:

• Represent the Design Quality function on device development project teams and cross functional co-ordination with multiple departments including R&D, Quality Control, Manufacturing and Regulatory Affairs.
• Ensure that device development projects and changes to existing devices are conducted in compliance with the FDA 21CFR Part 820 Quality System Regulation, ISO 13485 Regulations, and other applicable standards like ISO 14971.
• Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting devices can be adequately manufactured and verified.
• Lead or support design activities including design verification, validation, test procedure development, usability engineering, and risk management.
• Generate or apply statistical methods with appropriate risk-based justification.
• Hands-on experience in Design History File compilation / Technical file documentation.
• Support internal and external inspections/ regulatory audits.
• Promote continuous improvement in design control activities and use of quality tools with design team.
• In-depth knowledge and understanding of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, 21 CFR 4 Regulation of Combination Products, 14971 Risk Management Standard, MDD, MDR, IEC/EN 62366
• Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices

Secondary responsibilities (Wherever applicable):

• Experience interacting with regulatory agencies and notified bodies
• Experience with process improvements, process qualification and validation.
• Experience in complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance.

Educational Background & Experience:

• Engineering graduate (BTech/MTech) with a minimum of 5–8 years of relevant industrial experience preferably within medical device industries.

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.