Role: Technical Program Manager – R&D (Stent & Emerging Technologies) Experience: 10 Years (TAVI experience preferred) Location: Dehradun Plant (till Dec'26), thereafter Vizag Plant Key Responsibilities Establish and optimize manufacturing processes for transcatheter heart valve systems including: Tissue preparation and processing Valve assembly Stent integration Catheter assembly Delivery system manufacturing Balloon-expandable or self-expanding valve assembly Cleanroom manufacturing Sterile barrier packaging Final assembly & Device functional testing Lead end-to-end technology transfer programs from the U.S. manufacturing site to India. Develop and execute integrated project plans, schedules, budgets, milestones, and resource plans. Manage cross-functional global teams across engineering, manufacturing, quality, regulatory, supply chain, and operations. Drive governance meetings, executive reviews, risk assessments, and stakeholder communication. Monitor project KPIs including schedule, cost, quality, and readiness metrics. Identify technical and program risks and implement mitigation strategies. Lead replication of manufacturing processes from the U.S. facility to India with no compromise to product quality or performance. Ensure manufacturing processes, equipment, tooling, fixtures, test methods, and inspection methodologies are transferred successfully. Coordinate process characterization, engineering builds, pilot production, and production readiness. Develop and execute Technology Transfer Plans, Manufacturing Readiness Plans, and Process Validation Plans. Ensure knowledge transfer between global engineering and manufacturing teams. Mandatory Technical Expertise Technology Transfer TAVI (Transcatheter Aortic Valve Implantation) / TAVR / Transcatheter Heart Valve (THV) expertise Structural Heart & Class III Medical Device Manufacturing Manufacturing Process Development & Exact Process Replication Equipment Qualification & Commissioning Statistical Process Control (SPC) & Process Capability (Cp/Cpk) Technical Risk Management Strong Stakeholder Management & Executive Communication Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, or a related discipline. 10–15 years of experience in medical device manufacturing, with at least 5 years in Structural Heart. Hands-on experience in TAVI (Transcatheter Aortic Valve Implantation) / TAVR / Transcatheter Heart Valve (THV) product development, manufacturing, process engineering, or technology transfer. Strong computer skills with experience in Word, PowerPoint, Excel, Outlook, Microsoft Teams.
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