RND Project Manager-Medical Device

Summary

People who know this RND Project Manager, describe him as a trusted, authentic technical leader who has diversified experience in managing from small to large complex projects and hand-on experience / expertise in various areas within associated activities. The span of his experience includes various stages of new product development life cycle to product commercialization and follow ups through post market surveillance. This Project Manager also worked on numerous FDA 483 observations and helped client’s in achieving quality and compliance targets. He is 6 Sigma Black Belt certified and coached and trained employees in USA, Japan & Korea in CAPA’s, complaint handling, root cause investigations and made numerous improvements in product quality and contributed in robust product design and development process. He managed transition of legacy products from MDD to EU MDR and met EU MDR 2014/745 requirements. He worked with cross functional teams, coordinated with program subsystem teams and met project deliverables, synchronization and prioritization of core team activities. Evaluated impact of new released ISO standards, developed new assessment templates, revised SOP’s and brought back program overall timing by coordinating all development efforts through team ownership and commitment to project milestones. This RND Project Manager has a unique balance of technical, operational and financial savvy and has built a track record of identifying opportunity, and delivering differentiated products that catalyze profitable growth. Good understanding of regulatory requirements and standards applicable to medical devices, such as FDA regulations 21 CFR Part 820, ISO 13485:2016, ISO 14971:2019, ISO 10993, 62304:2006.

Highlights

Product Development / Design Control
Corrective and Preventive Actions (CAPA)
Quality Management System (QMS) – ISO 13485:2016 Quality Improvements (6 Sigma Certified)
Risk Management (ISO 14971:2019)
Supplier Management

Relevant Accomplishments

• Turned around program delays, prioritized team activities, developed project plans and milestones. Brought back program on track and met notified body submission schedules
• Led R&D team and improvements were made in Knee design and development process.
• Led Risk Management / Design Control workstream and reviewed / updated documents as per section 1, 3, 4 and 8 of Annex I of EU-MDR 2014/745. Reviewed design inputs (physical & performance characteristics), user needs, intended use (device- human interface), reviewed DFMEA’s, evaluated risk associated with, and occurring during the intended use and during foreseeable misuse. Set up design review meetings, reviewed design outputs, design verification data. Managed other Program Managers workstream activities and development of technical files and ensured products met the General Safety and Performance Requirements (GSPR).
• Supported corporate quality and compliance initiatives and helped in QMS ISO-13485:2016 implementation across organization and improvement in product development process.
• Cut down on backlog of customer complaints internal inconsistency, and associated CAPA’s. Led engineers and cross functional team members and performed retrospective review and remediation of reportable complaint event files. Identified product issues, developed feedback process and updated risk documents and improvements in product design.

Roles

• Principal Program Manager Regulatory (Consultant) -Cardinal Health
• Project leader Regulatory (Consultant) – Medtronic
• CAPA Project Manager (Consultant) – Zimmer
• Complaints and Quality Systems Leader (Consultant) – Terumo
• Cardiovascular Project Consultant Supplier Management – Abbott
• Project Leader Complaints and Non-Conformance (Consultant) – COOK
• Project Lead QA/ RA (Consultant) – Biomet 3i

Education / Certifications

• Master of Industrial Engineering (Columbia University – New York)
• Master of Business Administration (MBA)
• Bachelor of Mechanical Engineering
• Certification – Six Sigma Black Belt

Company / Industry Experience

• Abbott Laboratories Medtronic
• Cardinal Health
• COOK Medical
• Terumo Cardiovascular Biomet 3i
• Zimmer

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