Team Lead System Validation

Geplaatst op: 28-03-2019
Drachten

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.

Job Description

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

Progress

Status of objects under validation

Impediments

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

Minimum qualifications

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

International orientation

Willingness to learn and explore

Nice to have:

Programming experience (C#, Delphi)

Primary Work Location

NLD Drachten - Marconilaan

BD Kiestra

Nieuwsbrief

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