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We are searching for a Software Engineering Manager – Biotech for an exciting start up in the histopathology space. This company is revolutionizing microscopic diagnoses. This role is focused on artificial intelligence – AI, and machine learning, ML models. Software Engineering Manager – Biotech will report directly to the company’s CEO, and will be responsible for driving development of AI and ML products, setting and delivering strategic launch goals, “owning” the software development lifecycle.

Requirements for the Software Engineering Manager – Biotech:

  • MS; BS in Electrical Engineering, Computer Science, Software, Systems Engineering, or Biomedical Engineering.
  • 6+ years’ experience in software development
  • 3+ years’ experience in AI/ML models deployment, preferably computer vision models
  • Experience defining complex software and system architectures, trade studies and analysis of alternatives, defining and implementing best practices
  • A strong background generating technical documentation including requirements, specifications, engineering reports, SOPs
  • A track record of accomplishment developing and leading a high performance team of software developers
  • Excellent communications skills, oral, written, presentation
  • Exposure to or familiarity with digital pathology or other medical imaging modalities and standards preferred
  • Experience working in a highly regulated environment, ie healthcare, med devices or biotech preferred
  • Experience working on (SaMD) a software as a medical device preferred
  • Familiarity with approaches to deployment and configuration management of ML algorithms, particularly under continuous learning conditions preferred
  • Experience with medical device new product launch preferred
  • An understanding of FDA, MDD quality systems including, ISO 13485 and FDA 21 CFR 820, IEC 62366 and FDA guidance on medical device usability engineering
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Application Instructions: Please apply using the form or send your resume to Debbie Winkelbauer.