Our new CTO will lead the end-to-end process of assay and device development of multiple new high value in vitro diagnostic products through FDA (and global authorities’) clearance. The successful candidate will help set and drive company strategy in getting our breakthrough technologies into wide market adoption.

PRIMARY RESPONSIBILITIES:

  • Manage all aspects of diagnostic test system development for each new HostDx product, including assay, cartridge, instrument, software, system integration, and verification
  • Oversee all BSL-2 wet-lab functions including sample processing for analytical and clinical studies and assay research
  • Identify and manage relationships with key external technical partners
  • Performs technical due diligence on potential partners and acquisition targets
  • Work closely with cross-functional teams to bring HostDx products through FDA clearance and IVDR approval while meeting customer and market  requirements
  • Ensure a smooth transfer to manufacturing and proactively survey and manage technical issues that may occur in the field
  • Contribute to company strategic visions for both near-term and long-term success
  • Monitor and report on potential partners, competitors, and acquisition targets
  • Continue to build a world-class R&D team

QUALIFICATIONS:

  • 10+ years industry experience in diagnostic assay and/or device development
  • Experience taking IVDs through FDA clearance and providing technical leadership for on-market products
  • Track record of managing successful projects, including partnerships
  • Working knowledge of 21 CFR 820, ISO:13485 Quality System requirements and risk management processes (e.g. ISO:14971)
  • Prior work with gene expression / biomarker products a plus
  • Prior successful government contracting experience a plus
  • Experience in a start-up environment aligning multiple strategies and ideas
  • Track record of recruiting, building, and managing strong teams
  • Strong interpersonal skills working with peers and cross-functional teams
  • PhD in engineering, biology, or relevant field

SALARY AND CLASSIFICATION:

  • Classification: Full-time position located at Inflammatix headquarters in Burlingame, California
  • Compensation: Competitive and commensurate with experience
  • Benefits: Medical, dental, and vision; 401(k) and more.

HOW TO APPLY:  Please forward a cover letter and resume to:  jobs@inflammatix.com