Technical Program Manager

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.