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ML to decode a patient's immune profile and predict outcomes

Quality Assurance Manager

$100k – $120k
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Prenosis is on a mission to dramatically improve inpatient hospital care in the context of infectious diseases with Immunix, a platform that profiles patients’ immune systems in minutes and identifies those who could benefit from life-saving treatments prior to the onset of catastrophic illness. It utilizes machine learning algorithms trained on our proprietary NOSIS dataset, which is a collection of novel biomarker time series data that is coupled to clinical and outcomes data – the world’s largest and most rapidly growing dataset of its kind. The technology has the potential to save thousands of lives per year and millions of dollars in healthcare spending. Immunix will be the first FDA cleared machine learning powered sepsis algorithm and product.

Prenosis is at an exciting juncture in the lifecycle of our company. A few interesting developments as of late April 2020:
• Prenosis has recently signed a contracts to add 6,000 patients to the NOSIS dataset, making it the biggest Biobank and Dataset of its kind. This will present many interesting challenges from the a laboratory, data science, software engineering perspective.
• Prenosis is in advanced stages of discussion with a multinational diagnostics corporation to sign a collaborative contract whose primary aim will be to gain FDA clearance of our first product, Immunix ED. Though the framework to build the model has largely been fixed, many interesting technical challenges remain from a deployment perspective.
• Prenosis has initiated clinical studies at multiple hospitals in the context of COVID19 as of 04/23/20. The primary aim is to build a useful ML-based tool to risk stratify inpatient COVID19 positive patients using novel biomarkers and EMR data.

*Job Description *

We are looking for a Quality Manager who will aid in the development and implementation of the Quality Management System framework with a dual focus on software product development and clinical data quality control. The software product development will include design controls, DHF generation and risk management procedures in support of regulatory submission. The NOSIS dataset requires implementation of quality management procedures in relation clinical sample collection and laboratory processing. The position will work with Regulatory Affairs to support product regulatory submissions.

• Develop and maintain the Prenosis QMS and supporting procedures to adhere to FDA QSR/cGMP and ISO regulations (e.g., ISO 13485).
• Establish and maintain Prenosis QMS in support of product development, design controls, risk management, and supplier management systems.
• Establish and maintain Prenosis QMS in support of clinical data collection and laboratory operations.
• Support the creation of Prenosis data management plan.
• Ensure software compliance/design controls, as applied to medical device/IVD software, and Software as a Medical Device (SaMD).
• Lead the generation of required documentation and deliverables (e.g. DHF) throughout software development, including but not limited to SRS, SAD, SDS, V&V, trace-ability, risk management/FMEA and cyber-security.
• Maintain knowledge of the evolving regulatory landscape for Digital Health, Artificial Intelligence and Machine Learning technologies, and incorporate best practices in Tempus’ SDLC processes and QMS.

• BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.
• 5+ years in Quality experience in software product development, product transfer, verification, validation under Design Controls in the life sciences industry, preferably in a FDA regulated medical device/IVD environment.
• Experience and working knowledge of applicable regulations and standards: FDA QSR (21CFR Part 820), ISO 13485, IEC 62304, ISO 14971, 21CFR Part 11.

Preferred Qualifications
• Experience in Good Laboratory Practices, CAP/CLIA regulations and procedures.
• Expertise in SDLC best practices, and experience with state-of-the-art SDLC tools.
• Exposure to clinical studies best practices (e.g: GCP, Data Management,…)

Prenosis at a glance

ML to decode a patient's immune profile and predict outcomes

Prenosis focuses on Biotechnology, Medical Devices, Big Data, and Digital Health. Their company has offices in Chicago. They have a small team that's between 1-10 employees.

You can view their website at https://www.prenosis.com