Job Description Role: Technical Program Manager – R&D; (Stent & Emerging Technologies)
n Experience: 10+ Years (TAVI experience preferred)
n Location: Dehradun Plant (till Dec'26), thereafter Vizag Plant
n Key Responsibilities
n n Establish and optimize manufacturing processes for transcatheter heart valve systems including:
n Tissue preparation and processing
n Valve assembly
n Stent integration
n Catheter assembly
n Delivery system manufacturing
n Balloon-expandable or self-expanding valve assembly
n Cleanroom manufacturing
n Sterile barrier packaging
n Final assembly & Device functional testing
n Lead end-to-end technology transfer programs from the U.S. manufacturing site to India.
n Develop and execute integrated project plans, schedules, budgets, milestones, and resource plans.
n Manage cross-functional global teams across engineering, manufacturing, quality, regulatory, supply chain, and operations.
n Drive governance meetings, executive reviews, risk assessments, and stakeholder communication.
n Monitor project KPIs including schedule, cost, quality, and readiness metrics.
n Identify technical and program risks and implement mitigation strategies.
n Lead replication of manufacturing processes from the U.S. facility to India with no compromise to product quality or performance.
n Ensure manufacturing processes, equipment, tooling, fixtures, test methods,



and inspection methodologies are transferred successfully.
n Coordinate process characterization, engineering builds, pilot production, and production readiness.
n Develop and execute Technology Transfer Plans, Manufacturing Readiness Plans, and Process Validation Plans.
n Ensure knowledge transfer between global engineering and manufacturing teams.
n n Mandatory Technical Expertise
n n Technology Transfer
n TAVI (Transcatheter Aortic Valve Implantation) / TAVR / Transcatheter Heart Valve (THV) expertise
n Structural Heart & Class III Medical Device Manufacturing
n Manufacturing Process Development & Exact Process Replication
n Equipment Qualification & Commissioning
n Statistical Process Control (SPC) & Process Capability (Cp/Cpk)
n Technical Risk Management
n Solid Stakeholder Management & Executive Communication
n Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, or a related discipline.
n 10–15+ years of experience in medical device manufacturing, with at least 5 years in Structural Heart.
n Hands-on experience in TAVI (Transcatheter Aortic Valve Implantation) / TAVR / Transcatheter Heart Valve (THV) product development, manufacturing, process engineering, or technology transfer.
n Strong computer skills with experience in Word, PowerPoint, Excel, Outlook, Microsoft Teams.
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📌 Technical Program Manager (Haridwar)
🏢 V3 Staffing
📍 Haridwar