This person is responsible for the technical roadmaps, feature prioritization, software requirements, and specification definition related to Lab Information Management Systems (LIMS), laboratory automation, and software managing sample processing-to-result generation.

You will define and execute the multi-year technical roadmap for IVD/LDT software platforms, ensuring alignment with clinical needs and regulatory requirements.

Key responsibilities include:

• Leading feature prioritization and software requirements definition of LIMS, lab automation, and software managing the sample processing-to-result generation to optimize high-throughput sample processing and data integrity.

• Directing the integration of complex diagnostic hardware with cloud-based or on-premise processing software, focusing on seamless end-to-end workflows.

• Ensuring all software products comply with global regulatory standards, including FDA, CLIA/CAP, ISO 13485, and HIPAA/GDPR data privacy requirements.

• Collaborating with R&D, Molecular Biology, Clinical Lab, Lab Automation, and Engineering teams to translate complex assay protocols into automated, scalable software requirements.

• Managing cross-functional dependencies between wet-lab operations, bioinformatics pipelines, and software engineering teams to ensure timely product delivery.

• Establishing and monitoring key performance indicators (KPIs) for software reliability, processing speed, and diagnostic accuracy in a clinical laboratory environment.

Requirements include:

• 8+ years in Technical Product Management, with at least 4 years specifically in IVD, Medical Devices, or Clinical SaaS.

• Proven experience with LIMS/LIS and laboratory automation workflows.

• Deep familiarity with FDA software guidelines and CLIA regulations.

• BS/MS in Computer Science, Bioengineering, Molecular Biology, or a related field.

• Demonstrated experience managing and scaling technical product teams in a regulated environment.

Nice to have qualifications include:

• MS or PhD in a technical or scientific field.

• Experience with Next-Generation Sequencing (NGS) data pipelines.

• Hands-on experience with cloud infrastructure (AWS/Azure/GCP) in a GxP environment.

The US target range of our base salary for new hires is $220,400 - $281,400. You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered.

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