Responsibilities
- Develop and implement a long-term technical strategy for in vitro diagnostic and laboratory-developed test software platforms, aligned with clinical objectives and regulatory expectations.
- Lead the prioritization of features and define software requirements for laboratory information management systems, lab automation tools, and sample-to-result software to enhance high-volume processing and data accuracy.
- Oversee the integration of advanced diagnostic instruments with cloud or on-premise software platforms to enable smooth, end-to-end operational workflows.
- Guarantee that all software deliverables meet international regulatory standards such as FDA guidelines, CLIA/CAP regulations, ISO 13485, and data protection laws including HIPAA and GDPR.
- Work closely with research, molecular biology, clinical laboratory, automation, and engineering teams to convert intricate testing procedures into automated, scalable software specifications.
- Enforce adherence to a structured software development lifecycle for diagnostic software, spanning from concept through to market release for products managed by the technical product team.
- Coordinate dependencies across laboratory operations, bioinformatics, and software development groups to ensure on-time delivery of integrated solutions.
- Define and track performance metrics related to software stability, processing efficiency, and diagnostic precision within clinical lab settings.
Work Arrangement
Hybrid
