Project Manager Engineer
Infosys · Pune , India · 7-10 years · Full-time
Key skills
- Agile
Job description
We are looking for an experienced Project Manager Engineer with 7 - 10 years of experience in Medical Device Product Development and Lifecycle Management. The ideal candidate will lead cross-functional product development programs, manage project schedules, budgets, resources, and ensure successful delivery of innovative medical device products while maintaining compliance with quality and regulatory standards.
Technical Requirements:
Medical Device Product Development
Product Lifecycle Management (PLM)
Program & Project Management
Schedule, Budget & Scope Management
PMP Certified Project Management
New 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)
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.
Preferred Skills:
Domain->Product Development->Product Lifecycle Management,Foundational->Program Management->Program Management,Technology->Embedded Software->Medical Devices
Apply on the official Infosys careers page
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