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About this role
Job Summary
Responsibilities
Requirements
Preferred qualifications
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
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.
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.
Requirements
- 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.
Preferred qualifications
- 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.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Cost PlanningInstrumentationAgileCfrconfiguration managementFirmwareapplication softwareBiomedical EngineeringBiomedicalDiagnosticsdiagnosticChange ControlEmbedded SystemsBiotechnologydeploymentcloudCyber Securitycompliance
About Danaher
Danaher
Pharma
4.1k+
employees
1984
42 years old
Washington, District of Columbia
United States (USA)
₹18.6L PA avg
Avg at Danaher
About
Danaher is a science and technology innovator providing solutions for complex challenges, and improving quality of life around the world.
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PharmaManufacturingElectronicsMedical Equipment
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