Senior Systems Validation Lead

2 weken geleden

Drachten, Friesland, Nederland BD Kiestra Voltijd

Position Overview

The Lead Engineer for System Verification and Validation will oversee all verification and validation (V&V) efforts related to both software and hardware systems within New Product Development and Sustaining Engineering. This role requires active participation in multiple teams and the ability to initiate and guide sessions aimed at enhancing our operational methodologies.

About BD Kiestra

BD Kiestra is a prominent player in the global medical technology sector, dedicated to advancing health outcomes. Our mission is ambitious, and it requires the creativity and dedication of our team—from design and engineering to manufacturing and marketing—to transform innovative ideas into reality.

Key Responsibilities

  • Manage system V&V activities for complex projects.
  • Participate in risk management discussions.
  • Develop and maintain the System V&V plan and summary reports.
  • Act as a CAPA owner or task owner.
  • Implement effective system validation strategies and principles.
  • Enhance functional excellence through cross-site benchmarking, mentoring, and training.
  • Assist in resource allocation across various projects, ensuring alignment of personnel capabilities.
  • Communicate progress and status updates on validation efforts to project leads.
  • Foster a culture of continuous improvement in systems and processes, emphasizing quality and execution.
  • Collaborate closely with project leads, test engineers, developers, and functional analysts.
  • Ensure the accurate application of tools and systems.

Qualifications

  • Bachelor's or Master's degree in a relevant engineering discipline.
  • A minimum of 5 years of experience in verification and validation, preferably within the medical device, pharmaceutical, or biotechnology sectors.
  • Experience in project management, particularly in new product development initiatives.
  • Familiarity with working in a Quality Management System (QMS) regulated environment.
  • Proven ability to manage both technical and non-technical stakeholders.
  • Demonstrated success in implementing change in projects and processes.
  • Strong influencing, persuasion, and communication skills.
  • Excellent organizational and scheduling abilities.
  • Proficient command of the English language.

Conclusion

BD Kiestra is committed to fostering an inclusive and growth-oriented culture, providing opportunities for professional development while making a meaningful impact in the health sector.

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