Test and Verification Architect, Drachten, Friesland

About the company
We support an international organization in the medical devices industry, known for its innovation in hardware and system development. The company operates in both regulated (medical) and non-regulated (non-medical) environments, with a strong focus on quality, compliance, and cross-functional collaboration.

Role description
As a Test and Verification Architect, you will lead the verification strategy for hardware systems, ensuring comprehensive test coverage and alignment with release-level requirements. You will manage verification work packages, guide team members, and collaborate with stakeholders across engineering, quality, and project management. This role requires deep technical expertise, strong leadership, and a solid understanding of regulatory standards in the medical device domain.

Key responsibilities

• Define and execute verification strategies for hardware systems (approx. 70% medical, 30% non-medical).
• Identify and resolve design verification issues, including defect management and root cause analysis.
• Lead verification work packages and assign responsibilities within the team.
• Plan and ensure timely execution of verification activities.
• Deliver high-quality verification evidence in compliance with internal processes and external regulations.
• Provide technical input during design reviews and contribute to risk management.
• Optimize verification processes to improve team efficiency.
• Build and maintain a global verification network.
• Mentor team members in test method development and equipment management.
• Manage stakeholders across departments and ensure effective cross-functional collaboration.

• Bachelor’s or Master’s degree in Electrical Engineering, Electronic Engineering, Mechanical Engineering, Computer Science, or equivalent.
• Minimum 5 years of experience with a Bachelor’s degree OR 3 years with a Master’s degree in system architecture, system design, or hardware engineering.
• At least 3 years of experience in design verification for medical devices.
• Minimum 5 years of experience in R&D or laboratory environments.
• Strong understanding of engineering principles, hardware testing, and medical device development.
• In-depth knowledge of regulatory standards (FDA, ISO 13485, IEC, ISO 17025).
• Solid grasp of design control, test method development, MSA methodology, and statistical techniques.
• Strong leadership and project management skills.
• Excellent communication and documentation skills.
• Analytical mindset with problem-solving capabilities.
• Experience with Windchill and Minitab is a plus.
• Team-oriented and flexible in supporting multiple stakeholders.

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