Chetan Rajput A
Design Control Engineer for Medical Devices
- Role
- Assistant Manager at Biocon Biologics
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Chetan Rajput A
Senior Design Control Engineer with 9+ years of experience in medical devices and combination products. Proven expertise in leading design verification, risk management, and regulatory submissions for FDA and EU MDR compliance. Adept at driving cross-functional collaboration, implementing quality systems, and delivering measurable improvements in compliance, efficiency, and product reliability. Recognized for strategic leadership in verification/validation, regulatory documentation, and lifecycle management of medical devices.
Experience
Assistant Manager
Dec 2022 — Present · Bengaluru, IN
Led design verification strategy for drug-device combination products, ensuring FDA submission readiness and successful regulatory filing.• Directed cross-functional teams and external vendors to establish and validate test methods, reducing verification cycle time by 20%.• Implemented Electronic Laboratory Notebook (ELN) for inventory management and traceability, improving audit compliance and reducing manual errors by 30%.• Developed fixtures and executed performance qualification studies for critical instruments (UTM, torque testers, chambers), enabling faster in-house validation.• Authored SOPs and managed CAPAs, deviations, and change controls, strengthening compliance with ISO 13485 and FDA requirements.• Served as Department Training Coordinator, designing training programs that improved team competency scores by 25%.• Investigated product failures and provided technical justifications to regulatory agencies, ensuring closure of inspectional findings without penalties
Education
Vel Sri Rangarajan Sakunthala College Of Multimedia
Bachelor of Engineering (B.E.), Mechanical Engineering
2012 — 2016
Anna University Chennai
Master of Business Administration - MBA, Operations Management and Supervision
Skills
- Project Management
- Solidworks
- Presentation Skills
- Microsoft Office
- Marketing Communications
- Ansys
- Communication
- Ptc Creo
- Powerpoint
- Microsoft Word
- Catia
- Engineering
- Report Writing
- Autocad
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.