Job DescriptionRole: Technical Program Manager – R&D; (Stent & Emerging Technologies) NExperience: 10+ Years (TAVI experience preferred) NLocation: Dehradun Plant (till Dec'26), thereafter Vizag Plant NKey Responsibilitiesn N Establish and optimize manufacturing processes for transcatheter heart valve systems including: N Tissue preparation and processing N Valve assemblyn Stent integration N Catheter assemblyn Delivery system manufacturing N Balloon-expandable or self-expanding valve assembly N Cleanroom manufacturing N Sterile barrier packaging N Final assembly & Devicefunctional 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-functionalglobal 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. NnMandatory Technical Expertise Nn 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. N

📌 Technical Program Manager (Laksar)
🏢 V3 Staffing
📍 Laksar