Project Manager Engineer

Infosys Limited; Pune District; On-site; INR 1,500,000 - 2,700,000; Full time

Job summary

Infosys Limited in Pune seeks a Project Manager Engineer to lead end-to-end medical device product development efforts. The role demands managing scope, timelines, budgets, risks, and cross-functional coordination across R&D, Design, Quality, Regulatory, Manufacturing, and Supply Chain.

You will drive execution from concept to launch, ensure milestones, and oversee design control & lifecycle activities with ISO and FDA regulatory compliance.

Qualifications

• 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.

Responsibilities

• Monitor project deliverables and ensure adherence to 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 regulatory requirements.
• Mentor project teams and drive collaboration across functions.

Skills

Project management

Leadership

Stakeholder management

Communication

Risk management

Cross-functional leadership

Education

MTech

BE/Bachelor of Engineering

Tools

Windchill

Teamcenter

Agile PLM

Job description

PUNE , Infosys Limited Project Manager Engineer

Job ID/Reference Code INFSYS-INDEED1-255114

Work Experience 7 - 10 Years

Job Title Project Manager Engineer

Educational Requirements MTech,Bachelor of Engineering,BE

Service Line Engineering Services

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.Strong leadership, communication, and stakeholder management skills.

Technical and Professional Requirements: Medical Device Product DevelopmentProduct Lifecycle Management (PLM)Program & Project ManagementSchedule, Budget & Scope ManagementPMP Certified Project ManagementNew Product Development (NPD)Design Control & Change ManagementRisk Management (ISO 14971)Cross-functional Team LeadershipStakeholder & Vendor ManagementResource Planning & AllocationAgile & Waterfall MethodologiesProduct Commercialization & LaunchRegulatory Compliance (FDA, MDR, ISO 13485)

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