Responsibilities :

Lead end-to-end medical device product development projects.
Manage project scope, timelines, budgets, risks, and resources.
Coordinate with R&D;, Design, Quality, Regulatory, Manufacturing, and Supply Chain teams.
Drive project execution from concept through design, verification, validation, and product launch.
Monitor project deliverables and ensure adherence to project milestones.
Conduct project reviews, status reporting, and stakeholder communication.
Manage design control activities, product changes, and lifecycle management processes.
Identify and mitigate project risks and issues.
Ensure compliance with ISO 13485, ISO 14971, FDA, and other applicable regulatory requirements.
Support strategic planning, project governance, and continuous improvement initiatives.
Mentor project teams and drive collaboration across functions.

Additional Responsibilities :

PMP Certification.
Experience in Medical Devices, Healthcare Products, Diagnostic Devices, or Life Sciences industries.
Knowledge of PLM tools such as Windchill, Teamcenter, Agile PLM, or similar platforms.




Experience managing global or multi-site development teams.
Robust leadership, communication, and stakeholder management skills.

Technical and Skilled Requirements :

Medical Device Product Development
Product Lifecycle Management (PLM)
Program & Project Management
Schedule, Budget & Scope Management
PMP Certified Project Management
Recent Product Development (NPD)
Design Control & Change Management
Risk Management (ISO 14971)
Cross-functional Team Leadership
Stakeholder & Vendor Management
Resource Planning & Allocation
Agile & Waterfall Methodologies
Product Commercialization & Launch
Regulatory Compliance (FDA, MDR, ISO 13485)

Preferred Skills :

Domain->Product Development->Product Lifecycle Management,Foundational->Program Management->Program Management,Technology->Embedded Software->Medical Devices

Educational Requirements :

MTech,Bachelor of Engineering,BE

Service Line :

Engineering Services

📌 Project Manager Engineer Pune
🏢 Infosys
📍 Pune