Test and Verification Architect

You are responsible for
• Ensuring right hardware verification strategy (approx. 70% medical devices; 30% non-medical) by delivering proper test coverage, avoiding gap and overlap for release level requirements
• Identifying and resolving issues encountered during design verification, including support in management of design defects, root cause analysis and corrective actions
• Leading verification work packages and assigning ownership within T&V team
• Ownership of planning, ensuring timely execution of verification activities
• Ensuring high quality verification evidence (including compliance with processes, regulations and standards)
• Providing technical expertise during design reviews and contributing to risk management activities
• Boosting the effectiveness of the team by optimization of verification process
• Building effective global T&V network
• Mentoring and supporting team members within design verification process, development of tests methods and managing test equipment
• Managing stakeholders within and beyond own team, e.g. project managers, quality, development leads
• Effective collaboration and communication within cross- functional teams

Functie-eisen

To succeed in this role, you should have the following skills and experience
• Technical background, preferably electrical engineering, mechatronics, physics or comparable subject
• 3+ years of experience in design verification (medical devices)
• 5+ years of experience in R&D area or research laboratory
• 5+ years professional experience in medical device industry
• Strong understanding of engineering principles, hardware testing methodologies and medical device design and development process
• Deep knowledge of regulations, standards and quality systems, such as FDA regulations, ISO 13485, IEC standards, ISO 17025
• Solid understanding of Design Control • Solid understanding of test method development, MSA methodology/ test method validation, statistical techniques
• Strong leadership skills and project management skills
• Excellent written and verbal communication skills for documenting test plans, reports, and collaborating with cross- functional teams
• Strong analytical skills (careful data analysis, effective research, creative thinking and efficient problem solving)
• Excellent project management skills, including the ability to manage multiple priorities
• Strong sense of ownership, passionate, fast learner
• Good practice of Windchill and Minitab is an advantage
• Ability to work in team flexibility in order to work with and provide support for number of people,

Uiteraard staat deze vacature open voor iedereen die zich hierin herkent.