Job Description

Job Title Clinical Validation Specialist

Job title:
Clinical Validation Specialist
At Philips Enterprise Informatics (EI), we are at the forefront of AI innovation in medical software, empowering doctors and patients globally by providing detailed analysis and insights into clinical data and facilitating relevant workflows. As problem solvers, we are redefining the boundaries of what is possible in medical imaging and healthcare through advanced AI technology.
As a Validation Specialist in the Clinical Excellence team, you will play a crucial role in shaping the clinical validation of products, applications and solutions across all relevant Philips EI domains, including PACS, Digital Pathology, Cardiovascular, and more. You will collaborate with various Philips departments and Business Innovation Units (BIUs) such as MR and CT to ensure our innovative products meet regulatory compliance and achieve optimal customer satisfaction.
Key Responsibilities:

• Support the validation of innovative (AI) solutions and technologies, assessing their potential to address identified needs and challenges.
• Contribute to advancing healthcare technology by ensuring our innovations are safe, effective, and compliant with regulatory standards, ultimately improving patient outcomes.
• Plan, coordinate, and lead the execution of validation activities for our products and software applications, including setting up contracts and agreements with third parties.
• Develop, review, and approve validation documentation, including Validation Plans, Validation Protocols, Validation Reports, and properly document validation activities, including deviations, change control, and non-conformance management.
• Ensure validation strategies meet regulatory requirements and company standards.
• Ensure timely and effective completion of all validation activities in line with project objectives and schedules.
• Collaborate with cross-business and cross-functional teams, including quality & regulatory, system owners, business owners, engineering, service and platform teams, to track the progress of validation activities and work closely with product owners and product managers to ensure timelines align with the overall project plan.
• Stay updated on relevant changes to Philips' quality management systems and ensure validation practices align with evolving standards and identify opportunities for process improvements in validation activities.
• Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies.

You're the right fit if:

• You have experience in a clinical setting, with a preference for CT or MR technicians, or physicians.
• You have knowledge of design controls and international standards & regulations. (Prefered)
• You have knowledge in Statistics and Testing methodologies (prefered)
• You possess a proactive attitude, are quality-conscious, excel in communication, adeptly solve problems, and collaborate effectively within a team.
• You have a fluent level of English (verbal and written).
• You have experience in the validation of AI-based products (preferred).
• You have experience in Usability Engineering (preferred).
• You hold a degree in a medical field (preferred).

Experience:

• Minimum 2 - 5 years of experience in a clinical setting as a CT or MR technicians, or physicians.
• Preferably having some Experience in software validation projects.
• Experience in developing and executing test protocols, reports, and related documentation.
• Familiarity with statistics, computer system and software testing (preferred).
• Strong problem-solving and analytical skills.
• Excellent communication and teamwork skills.

Education and Professional Certifications:

• Bachelor's/Master's degree in Biomedical / Medical Imaging Technologies or related fields.
• Certification or experience in a relevant medical domain or technical field such as advanced image processing, or Artificial Intelligence, is a plus.

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How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company's facilities.
Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.
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About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

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If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .