Job Description Summary
Reporting to the Sr. Manager Systems Engineering, the candidate will be accountable for all system validation activities and deliverables in New Product Development and Sustaining Engineering. The Sr. System Validation engineer will lead a team of maximum 10 professionals (BSc and MSc level).
Within R&D the role has peers responsible for system and functional architecture, system integrators and system design, together forming an System Engineering group of approximately 30 FTE.
BD is a matrix organization, organizing R&D work in cross functional projects, under leadership of Core Team leaders (project managers). The key goal of the Sr. System Validation engineer is to create project validation strategies in line with Agile system engineering best practices and in compliance with medical device regulations, ensure professional execution of the system validation work in these projects; developing, guiding and coaching the associates in the department to ensure project success and the associates’ individual career development.
Duties and responsibilities
Manages system validation activities for complex projects
Takes part in risk management meetings
Creates System validation plan and summary report
Deploy best in class system validation strategies and principles
Grow functional excellence, through cross-site benchmarking, mentoring, training and functional reviews
Assure best possible allocation of resources across the various projects, aligning personnel capabilities and project needs
Manages test system availability
Communicates with project leads on
Status of objects under validation
Organize issue meetings
Support junior and medior system validation engineers
Closely collaborate with project leads, other test engineers, developers and functional analysts.
Develop and ensure proper use of tools and systems
Education and experience
Bachelor's or Master’s degree in relevant Engineering discipline
Minimum of 6 years of relevant work experience in verification and validation, preferable in medical device, pharma or biotech environment
Project management experience, preferably in new product development projects
At least 2 years functional management experience
Knowledge and skills
Knows how to translate risk assessment output into a System Validation approach
Knowledge of relevant standards and regulations, such as ISO13485, ISO14971, IEC62304, EU MDD/MDR, US 21CFR820
Able to assess requirements for System validation environment
Demonstrated expertise in managing technical and non-technical stakeholders
Demonstrated understanding of customers, microbiology workflow and industrial automation
Experience in working in a QMS regulated environment
Demonstrated ability to implement change (project and process)
Skills to influencing, persuade and constructively challenge plans and co-workers based on technical expertise and sound interpersonal skills.
Excellent organizational, communications and scheduling skills.
Excellent command of English language
Willingness to learn and explore
Nice to have:
Programming experience (C#, Delphi)
Primary Work Location
NLD Drachten - Marconilaan