Bellala Pavan Reddy

10+ years experienced systems engineer specializing in designing, implementing, and maintaining complex Medical Devices. Proven ability to drive projects to successful completion through seamless team collaboration and adaptability. Strong technical skills in systems quality, regulatory compliance, and agile methodologies. Known for reliability and achieving high-impact results in dynamic environments. Seeking opportunity to leverage skills in organizational and personal development.

• Domain: Systems Engineering – Medical Devices – R&D
• Experience: 10+Years (B.Tech in Mechanical Engineering)
• Certified Lead Auditor in ISO 13485 CQI and IRCA Medical Devices – Quality Management Systems by BSI
• Rich Experience in MQMS processes and ISO 13485 standards.
• Good knowledge in MDR/MDD.
• Sound knowledge in Verification & Validation, Design feasibility testing and developing V&V protocols and reports.
• Hands on Experience on using various PLM tools Agile(oracle) and TeamCenter Unified (TcU).
• Expertise in Test Method Validation according to 21 CFR 820.
• Good knowledge on Repeatability and Reproducibility (R&R) studies.
• Well versed in 21 CFR 820 QMS principles and can effectively apply on NPDs.
• Expertise in quality adherence and goal setting according to ISO 14971.
• Experience in understanding UDI, labelling and user instructions related to medical devices.
• Experience in Verification and Validation of the drawings.
• Expertise in preparing Protocols, Test Reports and Special Reports for New Products.
• Processing change notices for documenting and releasing the design changes to production in Windchill.
• Good knowledge in requirement management and mapping.
• Experience in Reverse Engineering.
• Carrying out cross functional team interactions emphasizing various aspects of Design and product development.
• Exposure to Class I & II medical devices like shunts, Catheters, Reservoirs, Needle Electrodes, Audiometry, Neonatal, Neuro and Renal surgical’s with their accessories.
• Developing proof of concepts, prototypes, specimen, sample size, NDT and acceptance criteria.
• Participating in concept design reviews with the engineering team.
• Leading a team to Coordinate, delegate, and manage plans.