Product Verification Architect – Medical Devices
Location: Drachten,The Netherlands
Company
Our client is a global leader in healthcare technology and innovation. They design and manufacture cutting-edge solutions that improve the lives of millions worldwide. With a strong focus on medical devices (approx. 70%) and non-medical hardware (30%), they are seeking a Test & Verification Architect to join their team.
What you’ll do
- Define and drive the hardware verification strategy, ensuring full test coverage without gaps or overlaps.
- Lead verification work packages, plan and assign activities, and ensure timely execution.
- Identify and resolve design verification issues, support defect management, root cause analysis, and corrective actions.
- Ensure high-quality verification evidence in line with regulations, standards, and quality systems.
- Provide technical expertise in design reviews and risk management activities.
- Mentor and support the team on test methods, equipment, and verification processes.
- Optimize verification processes to boost team effectiveness.
- Build and manage stakeholder relationships across global teams and functions.
What you bring
- Bachelor’s or Master’s degree in Electrical Engineering, Electronics, Mechanical Engineering, Computer Science, Mechatronics, Physics, or related.
- 5+ years of experience with a Bachelor’s OR 3+ years with a Master’s in System Architecture, System Design, Hardware Engineering, or equivalent.
- Strong background in design verification for medical devices.
- Experience in R&D, system testing, or research labs.
- Deep knowledge of regulations and standards: FDA, ISO 13485, IEC, ISO 17025.
- Strong grasp of engineering principles, hardware testing methodologies, and Design Control.
- Skilled in test method development, MSA/test validation, and statistical techniques.
- Proven leadership, project management, and stakeholder management skills.
- Strong analytical, communication, and problem-solving skills.
- Tools experience: Windchill and Minitab (advantage).
Why join
You’ll play a key role in shaping safe, effective, and innovative healthcare technologies that have global impact. You’ll work in a collaborative, cross-functional, international environment where your expertise makes a difference.56108
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Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
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