Project Manager

Capgemini Engineering; Pune District; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

Capgemini Engineering in Pune, India, seeks an experienced Project Manager to lead engineering delivery for medical device programs. You will define scope, plan milestones, track progress, manage budgets, and coordinate multi-disciplinary teams across offshore and onsite sites.

You will drive stakeholder reviews, governance meetings, risk mitigation, and ensure compliance with quality and regulatory standards such as ISO 13485, FDA QSR, and IEC 62304.

Responsibilities

• Define project scope, objectives, deliverables, and success criteria.
• Develop and maintain project plans, schedules, milestones, and resource plans.
• Track progress against commitments and drive timely closure of action items.
• Manage project budgets, forecasts, and utilisation.
• Serve as the primary point of contact for Bio-Rad project stakeholders.
• Facilitate project reviews, governance meetings, and status reporting.
• Coordinate communication between offshore, onsite, R&D, quality, manufacturing, and regulatory teams.
• Escalate project risks and issues appropriately and drive resolution.
• Identify project risks and develop mitigation plans.
• Manage issue logs, dependency tracking, and change control activities.
• Ensure corrective actions are implemented and verified.
• Lead decision-making discussions to minimise delivery impact.
• Ensure project activities comply with applicable quality and regulatory requirements.
• Support compliance with ISO 13485, FDA QSR, ISO 14971, IEC 62304, and related standards where applicable.
• Ensure documentation and engineering outputs meet Bio-Rad quality expectations.
• Participate in quality reviews, audits, and management review meetings.
• Coordinate multidisciplinary teams including: Mechanical Engineering, Software/Firmware Engineering, Verification & Validation, Quality and Regulatory Affairs, Manufacturing Engineering.
• Monitor engineering deliverables and technical progress.
• Ensure alignment with product lifecycle and sustaining engineering objectives.

Job description

• Define project scope, objectives, deliverables, and success criteria.
• Develop and maintain project plans, schedules, milestones, and resource plans.
• Track progress against commitments and drive timely closure of action items.
• Manage project budgets, forecasts, and utilisation.

Stakeholder Management

• Serve as the primary point of contact for Bio-Rad project stakeholders.
• Facilitate project reviews, governance meetings, and status reporting.
• Coordinate communication between offshore, onsite, R&D, quality, manufacturing, and regulatory teams.
• Escalate project risks and issues appropriately and drive resolution.
• Identify project risks and develop mitigation plans.
• Manage issue logs, dependency tracking, and change control activities.
• Ensure corrective actions are implemented and verified.
• Lead decision-making discussions to minimise delivery impact.

Quality & Regulatory Compliance

• Ensure project activities comply with applicable quality and regulatory requirements.
• Support compliance with ISO 13485, FDA QSR, ISO 14971, IEC 62304, and related standards where applicable.
• Ensure documentation and engineering outputs meet Bio-Rad quality expectations.
• Participate in quality reviews, audits, and management review meetings.

Engineering Delivery Oversight

• Coordinate multidisciplinary teams including:
• Mechanical Engineering
• Software/Firmware Engineering
• Verification & Validation
• Quality and Regulatory Affairs
• Manufacturing Engineering
• Monitor engineering deliverables and technical progress.
• Ensure alignment with product lifecycle and sustaining engineering objectives.