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.