Software Quality Engineer

About Prenosis

Prenosis Inc. is an artificial intelligence company pioneering precision medicine in acute care. Our Immunix™ precision medicine platform drives the development of precision products and enables real-time delivery of optimal therapy. We've created and validated the first FDA-authorized AI biomarker for sepsis, the Sepsis ImmunoScore™. Prenosis is headquartered in Chicago Illinois and generally operates on Central Time Zone.

We are seeking a Software Quality Engineer to join our growing team. The ideal candidate will have a strong background in software quality assurance, with a proven track record of working in a regulated environment, specifically with Software as a Medical Device (SaMD). This role will be critical in ensuring the quality, safety, and effectiveness of our AI-driven medical devices throughout their entire lifecycle. You will be a key contributor to our quality management system, working closely with cross-functional teams including software development, data science, clinical operations, and regulatory affairs.

Responsibilities

• Execute quality assurance activities for all product development activities.

• Collaborate on software design, development, and validation strategies, ensuring alignment with Quality Management Systems compliance requirements. 

• Partner with cross-functional teams, including marketing, R&D, clinical, and regulatory to deliver quality, compliant products. 

• Oversee risk management using ISO14971 standards to ensure product safety, including defining critical quality attributes, assessing residual risks, and presenting risk/benefit justifications to executive leadership. 

• Drive continuous improvement across the software lifecycle by implementing software industry best practices and regulatory standards.

• Engage in design and development activities for both medical and non-medical software.

• Ensure cybersecurity, data privacy, and interoperability are integrated into digital product design, reviewing software artifacts for compliance and traceability. 

Expected frequency and duration of travel: 10%

Qualifications and Experience

Required:

• Bachelor’s degree in Computer Engineering, Software Engineering, or Computer Science.

• Minimum of 3 years of experience working in a highly regulated industry in following cGMP and GDP regulations in the areas of Research & Development (R&D), Quality (QA/QC), or Systems Engineering. 

• Experience with regulatory agencies and medical device regulations (820, IEC 62304/82304, 60601), with experience in Software as a Medical Device (SaMD).

• Experience working through software lifecycle processes (Agile SAFe/Waterfall).   

• Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software testing and/or verification/validation.

• Experience working with cloud-based platforms (e.g., AWS, Azure, GCP)

• Excellent written and verbal communication and collaboration skills. The ability to work effectively with multi-disciplinary teams.

Preferred:

• Certification in software quality (ASQ Certified Software Quality Engineer, CSQE)

• Experience in testing and validating software with AI/ML algorithm components is highly preferred.

• Experience in programming languages including Python, SQL, R.

What We Offer

• Comprehensive Medical, dental, and vision coverage

• 401(k) with company match

• Unlimited PTO

• Major opportunity for career development to make significant impact at an exciting growth-stage company

• Collaborative and innovative work environment

• Chance to make a real impact on patient care

• Opportunity to work on cutting-edge AI technology in healthcare

Prenosis is an Equal Opportunity Employer

Must be eligible to work in the US without sponsorship