Ramprasad Sundaram
Project Program Management, Senior Technical Lead @HCLTech
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WORK HISTORY
Project Program Management, Senior Technical Lead @HCLTech
Chennai, IN
Led offshore delivery of 8+ R&D sustenance and NPI programs for interventional medicaldevices, managing cross-functional teams of 25+ engineers across design, quality, andregulatory functions.• Led migration and remediation of Design History Files (DHF), Risk Management Files, andtechnical documentation into Polarion ALM, strengthening traceability and regulatorycompliance under FDA 21 CFR 820 and ISO 13485.• Contributed cognitively to product development phases adhering to FDA andISO-13485:2016 standards.• Program-managed EU-MDR remediation initiatives & Sustenance Engineering acrossR & D, Quality, and Labeling for cardiovascular intervnetions and oncology devices,ensuring uninterrupted market access and audit readiness.• Directed design verification efforts in compliance with ISO-80369-7 for Luers and Hubs & mis-connection and Tolerance Stack-up Analysis for compliance with ISO-80369-7• Spearheaded Technical Design and Phase Gate Reviews for New Product Development inTarget Temperature Management devices.• Innovating Smart Connectors and Next Gen designs by uniting on-site and offshoreteams.• Conducted techno-commercial presentations with client partners, aligning productcapabilities to fiscal year targets and securing key business requirements.
EDUCATION
KCG College of Technology
Bachelor of Engineering (B.E.), Mechanical Engineering
Sikkim Manipal University (SMU)
Master of Business Administration (MBA)
Sairam Polytechnic College
Diploma In Mechanical Enginnering, Mechanical Engineering
Shankara Vidhyalaya Matric, Hr, sec
SSLC, SSLC
ABOUT RAMPRASAD SUNDARAM
Project Manager with 13+ years of experience delivering FDA and EU-MDR-compliantmedical devices and electromechanical products. Skilled in partnering with businessdevelopment leaders and client stakeholders to deliver compelling product capabilitypresentations and techno-commercial demonstrations, effectively translating technicalstrengths into customer value propositions and competitive advantage. Experienced instakeholder management across US, EU, and offshore teams.
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