Project Manager

Overview

Lead complex, cross-functional medical device projects across hardware, embedded firmware, application software, cybersecurity, systems engineering, manufacturing, and service readiness, from concept through development, verification and validation, regulatory support, launch, and post-market sustainment.

What you'll do

• Lead cross-functional systems projects with accountability for scope, schedule, resources, budget, quality, technical performance, and delivery across all key functions.
• Build and maintain integrated project plans covering requirements, design reviews, verification and validation, regulatory activities, manufacturing transfer, launch readiness, dependencies, critical paths, and recovery actions.
• Establish Waterfall, Agile, or hybrid governance, facilitate core-team and phase-gate reviews, and document decisions, risks, actions, escalations, owners, and due dates.
• Partner with technical and functional leaders to integrate hardware, firmware, and software while ensuring interoperability, requirements traceability, configuration control, and coordinated system testing.
• Ensure compliance with Cepheid's Quality Management System and applicable design-control and software-lifecycle processes, including required project, risk, verification, validation, cybersecurity, design-transfer, and launch documentation.
• Manage program and product-development risks, issues, and opportunities using risk-based decisions, structured problem solving, mitigation plans, and timely escalations.
• Track and communicate schedule, budget, resource, risk, quality, and milestone performance while coordinating commercialization, launch, lifecycle changes, and continuous improvement.

What you'll need

• Bachelor's degree in engineering, computer science, or biomedical engineering with 7+ years of relevant experience, or a related master's degree with 5+ years of relevant experience.
• At least 5 years of project or program management experience leading cross-functional product development, including delivery of a complex system or electro-mechanical product involving at least two of the following: hardware, firmware, software, consumables, or connected/cloud capabilities.
• Strong project-management experience in integrated scheduling, resource and cost planning, risk and issue management, change control, stakeholder communication, and Waterfall, Agile, or hybrid governance.
• Experience in regulated medical devices (21 CFR Part 820), in vitro diagnostics, life sciences, or scientific instrumentation, with knowledge of design controls, product risk management, verification and validation, design transfer, and controlled documentation.

Nice to have

• PMP, PRINCE2, Scrum, SAFe, or a comparable project/program management certification.
• Regulated software or firmware release experience, including cybersecurity, secure development, deployment, configuration management, or post-market updates.
• Experience with manufacturing transfer, commercialization, sustainment, or continuous improvement for complex medical device or diagnostic systems; Danaher Business System experience is valuable.

Details

• Reports to the Senior Manager and is part of the Program Management Office (PMO) located in Bengaluru, India.
• On-site role.