United States onlyAbout 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 Design Quality Engineer (SaMD) 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%
Requirements
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
