Jaishnu Padman

About Jaishnu Padman

I am a PMP certified Project Management professional with 9+ years of experience delivering complex, regulated projects in the medical device industry. My expertise spans end-to-end project execution, stakeholder engagement, and cross-functional team leadership across global locations.I specialize in Hybrid, Agile and Waterfall methodologies, risk management, Design and Quality Assurance and process improvement initiatives, ensuring projects are delivered on time, within budget, and in compliance with ISO and FDA standards. With a strong background in strategic planning, resource allocation, and governance reviews, I have successfully driven initiatives that improved efficiency and reduced risks in high-stakes environments.Recognized for innovation and leadership, I hold a patent and have received multiple awards for excellence in project delivery and team performance. I am passionate about building collaborative teams, optimizing processes, and delivering value-driven solutions that meet business objectives and regulatory requirements.Core Strengths: Project Lifecycle Management | Medical Device: Design and Development | Design Assurance | Stakeholder Engagement | Agile/Scrum Delivery | Risk Management | Process Optimization~ Experienced Project Manager for Medical device developmental projects~ Project Management Professional Certification~ 9+ years of experience in the Medical Devices Industry.~ Skilled in mechanical design release~ Proven leadership in developing and executing design assurance efforts~ Coordinate Risk Management activities (PHA, FTA, FMEA/FMECA) by identifying the risks associated with the device and deriving possible mitigation strategies.~ Excellent working knowledge of EU MDR, FDA 21 CFR 820, and other regulations.~ Experience in driving diverse Design & Development efforts such as developing design input requirement specifications, conducting Premarket study through Competitor Analysis and Literature Review, Design reviews, Unit Testing and Post-market assessment.~ Proficient in implementing Agile way Working in the MD product development process and drive cross-functional scrum teams to complete deliverables as planned.~ Expertise in overseeing and coordinating internal quality reviews and external client audits, based on ISO 13485 and FDA requirements and implementing suggested corrective actions as necessary.~ Ensuring product compliance with quality standards and regulatory requirements.~ Certified Contextual Master from TCS

Experience

1. Project Lead

   Tata Consultancy Services

   Aug 2022 — Present · Bengaluru, IN

   Project Lead and Design Assurance specialist delivering complex Class medical device development programs for global manufacturers within highly regulated environments. Led end-to-end product development initiatives encompassing project planning, scheduling, design development, verification and testing, governance reviews, and stakeholder communication across multi-site, cross-functional teams.Served as the primary onsite client interface, aligning senior client stakeholders with offshore delivery teams across mechanical design, PCBA development, prototyping, verification, and DHF documentation. Proactively drove milestone readiness, risk mitigation, and informed decision-making by identifying and resolving delivery risks, dependencies, and execution challenges.Demonstrated strong leadership in Agile/Scrum delivery, mechanical design development, change management, and design assurance, ensuring compliance with global medical device regulations and standards. Instrumental in establishing robust governance frameworks, KPI dashboards, and executive reporting mechanisms that enhanced delivery transparency, risk escalation, and leadership visibility. Actively strengthened configuration management, design reviews, and DHF development to improve regulatory compliance, audit readiness, and overall product quality.Core Strengths: Project & Program Management | Medical Device: Design and Development | Stakeholder Relationship Management | Agile/Scrum Delivery | Risk Management | Design Assurance | Change & Configuration Management

Education

• NSS College of Engineering, Palakkad

  Bachelor of Technology - BTech, Mechanical Engineering

• Jawahar Navodaya Vidyalaya - JNV

  Matriculation, +2, Mathematics and Computer Science