Principal AI Quality Engineer

Danaher Corporation•Vista, CA

2d•Onsite

About The Position

The AI Quality Engineer leads quality assurance efforts for AI‑driven medical device software, overseeing end‑to‑end lifecycle development and compliance activities for Artificial intelligence (AI)/machine learning (ML) models to ensure safety, effectiveness, and regulatory alignment. This role partners closely with R&D, clinical, regulatory, and product teams to guide AI/ML solutions through rigorous quality and compliance processes. The engineer also mentors junior team members, strengthens cross‑functional collaboration, and upholds the highest standards of product quality throughout the organization. This position reports to the Director, Quality Assurance and Regulatory Compliance and is part of the Quality team located in Vista, CA and will be an on-site role.

Requirements

Bachelor’s or master’s degree in computer science, Data Science, Artificial Intelligence or a related technical field; advanced degree preferred, with 5+ years of quality experience in medical devices, IVD, or similarly regulated industries.
Deep expertise in AI/ML algorithms, model validation, evaluation techniques, and regulated software or embedded software development.
Strong knowledge of regulatory standards for AI/ML and SaMD, including FDA 21 CFR Part 820, IEC 5338, ISO 13485, IEC 62304, and FDA AI/ML guidance.
Proven ability to lead AI‑focused risk management processes, supported by strong analytical skills and a commitment to patient safety and product quality.
Demonstrated leadership, project management, and communication skills, with experience across AI/ML, Digital Health, Cybersecurity, and Interoperability.

Nice To Haves

Familiarity with Good Machine Learning Practices (GMLP) and FDA’s AI/ML regulatory framework.
Experience with post-market surveillance and monitoring of AI/ML models.
Knowledge of digital health, cybersecurity, interoperability, and cloud-based SaMD deployment considerations.
Effective presentation and communication skills, with ability to engage both technical and non-technical stakeholders.
Strong organizational and project management skills to meet regulatory and product development timelines.

Responsibilities

Represent the Quality Engineering function on cross‑functional teams, contributing to design controls, process controls, verification/validation activities, and Design History File development.
Lead the development and execution of AI/ML quality assurance strategies aligned with global regulations and standards, including FDA, MDR, IVDR, IEC 5338, IEC 23053, EC 8183, IEEE 2801, ISO 13485, and IEC 62304.
Partner with data scientists, software engineers, and clinical experts to ensure AI/ML solutions meet clinical, regulatory, and performance expectations.
Support global regulatory submissions, such as FDA pre‑subs, 510(k), and IVDR CE, while driving AI/ML risk management, including hazard analysis, mitigation planning, and evaluation of model robustness, bias, and fairness.
Lead AI/ML lifecycle quality activities, including V&V best practices, CAPA and root‑cause investigations, audit/inspection readiness, and mentoring of junior engineers while staying current on evolving regulatory and industry trends.