Key skills
Medical device developmentRegulatory submissionDiagnostics product developmentUS FDA regulatory frameworkEU IVDR regulatory frameworkCancer geneticsImmunologyMolecular biologyNext-generation sequencing dataAlgorithms developmentSoftware systems validationverificationSelf-drivenAI
About this role
Tempus AI is a company passionate about precision medicine and advancing the healthcare industry. They are seeking a highly motivated Technical Product Manager to manage software development processes and support bioinformatics software development functions in the field of cancer genomics.
Responsibilities:
- Managing software development lifecycle processes
- Engaging with the quality and regulatory team and supporting quality processes
- Incident management: Promptly triage, coordinate, and manage the resolution of issues
- Stakeholder support: Provide dedicated and responsive support to all stakeholders using the bioinformatics software
- Feature request intake and prioritization: Collect, prioritize, and manage feature requests to guide software development
- Interfacing with Product Managers of downstream engineering teams during implementation
- Data contract management with downstream engineering teams
- Documentation: Maintain comprehensive and up-to-date documentation for all bioinformatics software
Requirements:
- Bachelors or M.S. in a scientific discipline
- Significant experience in medical device development and regulatory submission
- 2-4 years relevant experience in diagnostics product development
- Familiarity with US FDA and EU IVDR regulatory frameworks
- A track record of successful submissions to US and international regulatory agencies
- Experience in cancer genetics, immunology, or molecular biology
- Experience working with next-generation sequencing data
- Self-driven and works well in interdisciplinary teams
- Experience with communicating insights and presenting concepts to a diverse audience