Design Quality Engineer (SaMD)

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 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%

Qualifications and Experience

Required :

Preferred :

What We Offer

Prenosis is an Equal Opportunity Employer

Must be eligible to work in the US without sponsorship