P

Philips

Makes medical devices and personal health products

Senior Software Design Quality Engineer - AI

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeBest, NetherlandsIn-person

About the Job

Requirements

  • A Bachelor's degree in Software Engineering, Computer Science, or a related field; a Master's degree is preferred.
  • At least 15 years of experience.
  • Experience in new product development and lifecycle management projects as a Design Quality Engineer.
  • Technical skills in C++, C#, Python, or another programming language are a plus.
  • Sound understanding of regulatory requirements and standards, including ISO 13485, ISO 14971, IEEE 1633, FDA regulations, IEC 62304, and AI regulations.
  • Sound understanding of AI foundation models, prompt engineering, and data processing techniques.
  • Experience with automated testing tools and frameworks such as Selenium, JUnit, or PHPUnit.
  • Experience with Agile methodologies and tools.
  • Knowledge of regulatory standards and compliance related to software quality assurance and AI.

Responsibilities

  • Lead Design Quality Engineering activities for assigned projects across the full software product lifecycle, from concept to commercialization.
  • Drive compliance with design control processes, including ISO 13485, IEC 62304, ISO 14971, IEEE 1633, and AI regulation frameworks such as EU AI Act-ready practices.
  • Partner in defining and maintaining quality strategies and key performance indicators for complex, multi-component systems integrating software, cloud, data, and AI/ML in compliance with applicable regulations and standards.
  • Oversee quality planning, documentation, and reviews for software and AI-enabled solutions, including foundation models and prompt engineering.
  • Design quality assurance for deep neural networks and govern training pipelines for reproducibility.
  • Ensure robust validation strategies for artificial intelligence models, including dataset quality, model performance, bias detection, and continuous learning.
  • Partner with research and development teams to ensure transparency, explainability, and traceability in AI model development.
  • Oversee risk management activities under ISO 14971, including hazard analyses, failure mode and effects analyses, fault tree analyses, cybersecurity risk assessments, and AI-specific risks.
  • Evaluate design robustness and reliability using data-driven methods and statistical techniques.
  • Collaborate with research and development teams and conduct expert-level design reviews on architecture, algorithms, code, test strategy, and verification and validation evidence.
  • Identify design gaps early and drive cross-functional remediation.
  • Serve as a quality subject matter expert during regulatory submissions and audits.
  • Mentor teams in quality engineering best practices.
  • Support development of advanced processes for AI product lifecycle, dataset governance, software traceability, DevOps, and continuous quality monitoring.
  • Champion a culture of Quality by Design across research and development.

Desired Qualifications

  • A Master's degree in Software Engineering or Computer Science.

About the Company

Philips

Makes medical devices and personal health products

Philips makes medical equipment and software for hospitals and care providers, along with personal health products for consumers. Its hospital portfolio spans MRI and CT scanners, ultrasound, image-guided treatment systems and patient monitors, while Sonicare and Avent cover oral health and baby care. Clinical software connects medical images and patient data across care teams, and the company earns revenue from equipment, software, maintenance and consumer product sales. It works with health systems through long-term technology and service partnerships, including solutions for care at home. Founded in 1891, Philips is headquartered in Amsterdam, the Netherlands.

Company size
10,001+
Company stage
Acquired
Total funding
$164.7M
Headquarters
Andover, MN
Founded
1891

Recently Posted Jobs

Explore more opportunities at Philips

See more jobs