Job Summary

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.

Roles & 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.





Technical 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)

Additional Responsibility

- 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.
- Strong leadership, communication, and stakeholder management skills.

Educational Requirement

- MTech, Bachelor of Engineering, BE

Preferred Skills

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

Service Line

Engineering Services

📌 Project Manager Engineer (Pune)
🏢 Infosys
📍 Pune