Principal AI Quality Engineer

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

At Leica Biosystems one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

At Leica Biosystems were not just shaping the future of cancer diagnostics were transforming lives. Our mission of Advancing Cancer Diagnostics Improving Lives is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis we empower clinicians with innovative reliable solutions so they can give patients timely accurate answers when they need them most. When you join Leica Biosystems youre not just taking a job; youre becoming part of a passionate team that knows every moment matters when it comes to cancer. Youll help develop diagnostic solutions that turn anxiety into answers and aid the acceleration of next-generation life-changing therapies. Surrounded by a diverse and collaborative global community youll be inspired each day to stretch grow and make an impact.

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The AI Quality Engineer leads quality assurance efforts for AIdriven medical device software overseeing endtoend 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 crossfunctional 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.

In this role you will have the opportunity to:

• Represent the Quality Engineering function on crossfunctional 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 presubs 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 rootcause investigations audit/inspection readiness and mentoring of junior engineers while staying current on evolving regulatory and industry trends.

The essential requirements of the job include:

• Bachelors or masters 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 AIfocused 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.

It would be a plus if you also possess previous experience in:

• Familiarity with Good Machine Learning Practices (GMLP) and FDAs 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.
• Possible international

Leica Biosystems a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

The annual salary range for this role is $160000 - $180000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

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Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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