Divyesh Patwa Email & Phone Number

* 21+ years of Professional experience and 15+ years of leadership role.* Expertise in project management for class 3 implantable medical devices (Drug Eluting Stent & PTCA catheter).* Expertise in Technology transfer projects for PTCA catheter and Self expandable stent delivery system.* Expertise in bio-resorbable and drug eluting stent crimping process development & Validation.* Expertise in PTCA catheter manufacturing process control, validation, and testing and cost control. * Projects and production management and control.* Expertise in developing nonclinical engineering test methods for PTCA Catheters and Stent systems as per ISO 25539, ISO10555, USFDA and ASTM standards.* Product benchmarking and evaluation and technical report writing for regulatory submission and marketing material.* Highly Experienced c-GMP/Indian FDA/USFDA professional and experienced Internal Quality auditor.* Experience in new supplier development and management.* Expertise in people’s recruitment, training, coaching, mentoring and management. Production planning, capacity built up and operational cost reduction. * Expertise in process validation, control, monitoring and analysis.* Excellent leadership, strategic thinking, and team management.* Multitasking, problem solving and analytical thinking.* Excellent verbal and written communication & interpersonal skill.* Cooperative and positive attitude, committed to work and self-driven.* Loyal, Honest, Sincere, Hardworking, flexible & adaptable and a good motivator.

Listed skills include Iso 13485, Fda, Quality System, Medical Devices, and 27 others.