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 Responsibilities

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- Establish and optimize manufacturing processes for transcatheter heart valve systems including:
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- Tissue preparation and processing
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- Valve assembly
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- Stent integration
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- Catheter assembly
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- Delivery system manufacturing
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- Balloon-expandable or self-expanding valve assembly
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- Cleanroom manufacturing
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- Sterile barrier packaging
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- Final assembly & Devicefunctional testing
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- Lead end-to-end technology transfer programs from the U.S. manufacturing site to India.
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- Develop and execute integrated project plans, schedules, budgets, milestones, and resource plans.
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- Manage cross-functionalglobal teams across engineering, manufacturing, quality, regulatory, supply chain, and operations.
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- Drive governance meetings, executive reviews, risk assessments, and stakeholder communication.
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- Monitor project KPIs including schedule, cost, quality, and readiness metrics.
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- Identify technical and program risks and implement mitigation strategies.
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- Lead replication of manufacturing processes from the U.S. facility to India with no compromise to product quality or performance.
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- Ensure manufacturing processes, equipment, tooling, fixtures, test methods, and inspection methodologies are transferred successfully.




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- Coordinate process characterization, engineering builds, pilot production, and production readiness.
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- Develop and execute Technology Transfer Plans, Manufacturing Readiness Plans, and Process Validation Plans.
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- Ensure knowledge transfer between global engineering and manufacturing teams.
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nMandatory Technical Expertise

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- Technology Transfer
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- TAVI (Transcatheter Aortic Valve Implantation) / TAVR / Transcatheter Heart Valve (THV) expertise
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- Structural Heart &

• Class III Medical Device Manufacturing

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- Manufacturing Process Development &

• Exact Process Replication

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- Equipment Qualification&

• Commissioning

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- Statistical Process Control (SPC) &

• Process Capability (Cp/Cpk)

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- Technical Risk Management
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- Strong Stakeholder Management &

• Executive Communication

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- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, or a related discipline.
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- 10–15+ years of experience in medical device manufacturing, with at least 5 years in Structural Heart.
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- Hands-on experience in TAVI (Transcatheter Aortic Valve Implantation) / TAVR / Transcatheter Heart Valve (THV) product development, manufacturing, process engineering, or technology transfer.
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- Robust computer skills with experience in Word, PowerPoint, Excel, Outlook, Microsoft Teams.
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📌 Technical Program Manager (Laksar)
🏢 V3 Staffing
📍 Laksar