The role involves driving the day-to-day execution of the Lumira Assay development roadmap to translate product vision into prioritized work packages
Job Summary
The role involves driving the day-to-day execution of the Lumira Assay development roadmap to translate product vision into prioritized work packages.
You will foster a culture of high-impact collaboration by uniting R&D, Operations, Quality, Regulatory, and Clinical teams to ensure shared ownership of project success.
The position requires upholding the highest standards of technical integrity and quality compliance while navigating complex regulatory guidelines including CLSI, IVDR, and FDA requirements.
Matching Summary
The role involves driving the day-to-day execution of the Lumira Assay development roadmap to translate product vision into prioritized work packages.
Skills & Requirements
Must-have
IVD assay development experience
CLSI IVDR FDA ISO NMPA knowledge
Cross-functional matrix leadership
Agile SAFe project management
Risk management scenario planning
Nice-to-have
Culture of open communication
Deep scientific diagnostic principles
Hands-on driver of execution
Continuous improvement mindset
Key Requirements
Significant IVD or Medical Device industry background
Proven track record delivering complex projects from definition to launch
Experience with Agile/SAFe and traditional project management methodologies