Project Manager Engineer

Infosys; Pune District; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Infosys is seeking an experienced Project Manager Engineer with 7-10 years of experience in Medical Device Product Development and Lifecycle Management. The role leads cross-functional programs, manages schedules, budgets, resources, and ensures timely delivery of compliant medical device products.

The ideal candidate will oversee design controls, risk management, and regulatory activities across ISO 13485, ISO 14971, FDA requirements, while mentoring teams and driving continuous improvement.

Qualifications

• 7-10 years in medical device product development and lifecycle management.
• Experience in design controls and change management.
• PMP certification preferred.
• Knowledge of ISO 13485, ISO 14971, FDA regulatory requirements.

Responsibilities

• Lead end-to-end medical device product development programs.
• Manage project schedules, budgets, scope, and resources.
• Coordinate with R&D, Design, Quality, Regulatory, Manufacturing, and Supply Chain teams.
• Drive execution from concept through design, verification, validation and launch.
• Monitor milestones and provide status reports to stakeholders.
• Mentor project teams and drive cross-functional collaboration.

Skills

Project management

Cross-functional leadership

Risk management

Stakeholder management

Agile & Waterfall

Vendor management

Mentoring

Regulatory compliance

Education

MTech or BE/BTech in Engineering

Tools

Windchill

Teamcenter

Agile PLM

Job description

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
• 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)

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