Project Manager

Cepheid; Bengaluru; On-site; INR 3,000,000 - 5,000,000; Full time

Job summary

Cepheid in Bengaluru, India, is seeking a Project Manager for Systems (Hardware, Firmware & Software) to drive complex product development across hardware, firmware, and software domains. The role reports to the Senior Manager within the PMO and requires on-site presence in India.

You will coordinate cross-functional teams, manage schedules and risk, ensure regulatory compliance, and align design-transfer and launch activities with quality systems.

Qualifications

• Bachelor’s degree in engineering, CS, or biomedical engineering with 7+ years of relevant experience, or a related master’s degree with 5+ years.
• 5+ years of project or program management leading cross-functional product development in a complex system or electro-mechanical product.
• 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.

Responsibilities

• 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.

Skills

Project management

Cross-functional leadership

Waterfall/Agile governance

Regulatory compliance

Risk and issue management

Requirements traceability

Education

Bachelor's degree in Engineering

Master’s degree in a related field

Job description

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cepheid, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world’s most complex health challenges. Together, we bring MORE change to the world.

Learn about the Danaher Business System which makes everything possible.

The Project Manager, Systems (Hardware, Firmware & Software) leads 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.

This position reports to the Senior Manager and is part of the Program Management Office [PMO] located in India, Bengaluru and will be an on-site role.

In This Role, You Will Have The Opportunity To

• 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.

The Essential Requirements Of The Job Include

• Bachelor’s degree in engineering, computer science, 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.

It would be a plus if you also possess previous experience in:

• 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.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.