Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.
But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.
The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.
We are seeking a highly motivated System Validation Architect to play a pivotal role in our medical device development process. This role requires an individual who excels in cross-functional leadership, independent work, and medical device validation. The ideal candidate will ensure that our products meet user needs and intended use through rigorous validation processes.
Responsibilities
Lead system validation activities throughout the medical device lifecycle, ensuring compliance with regulatory requirements.
Define, document, and continuously improve validation test strategies, plans, and protocols.
Conduct validation tests, analyze results, and drive technical issues to resolution.
Collaborate closely with cross-functional teams, including R&D, Quality, Regulatory, Clinical, and Usability teams.
Maintain traceability of validation activities to system requirements.
Lead and participate in design reviews, ensuring the robustness of validation plans, reports, and test artifacts.
Develop and execute validation test plans, records, and test fixtures.
Ensure compliance with national and international medical device validation standards.
Provide technical leadership and mentorship in system validation best practices.
Stay updated with emerging trends, regulations, and technologies in medical device validation.
Qualifications
Bachelor’s or Master’s degree in Engineering (Electrical, Electronics, Mechanical, or related field).
10+ years of experience in system validation, preferably in medical devices.
Deep knowledge of FDA CFR 21 Part 820.30, IEC 60601-1-1, ISO 13485, and risk management standards.
Strong understanding of design validation methodologies and regulatory compliance for Class III medical devices.
Experience in usability engineering, clinical research, and medical claims substantiation.
Strong technical writing and documentation skills for regulated environments.
Proven ability to communicate in both verbal and written form to technical and non-technical customers, stakeholders, and various levels of management.
Possess strategic agility/vision: Sees ahead clearly; can anticipate future concerns.
Demonstrated leadership, strategic vision, and cross-functional collaboration abilities.
Proven ability to work independently as a self-starter in a fast-paced environment.
Excellent communication and stakeholder management skills.
Why Join Us?
Be part of a team that develops life-saving medical technologies.
Collaborate with top experts in the medical device industry.
Drive impactful validation strategies in a dynamic and innovative work environment
If you are passionate about ensuring the safety, efficacy, and reliability of medical devices and excel in cross-functional leadership, we encourage you to apply!
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How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.