Nuclear Device Verification Specialist

2 weken geleden

Apeldoorn, Gelderland, Nederland NonStop Consulting Voltijd
  • Job Summary
  • We are seeking a highly skilled Verification and Validation Engineer to lead the development and optimization of neutron activation processes for holmium microspheres.
  • This role requires a strong understanding of regulatory standards and the ability to ensure compliance with ISO 13485, ISO 14971, FDA 21 CFR Part 820, and radiological safety requirements.
  • The ideal candidate will have a background in biomedical engineering, nuclear engineering, material science, medical physics, or a related field.
  • Experience with neutron activation or radioisotope production is highly desirable.
  • This position involves designing and optimizing neutron activation processes, leading and executing verification and validation protocols, and ensuring compliance with regulatory standards.
  • The successful candidate will be able to conduct risk assessments, develop mitigation protocols, and prepare comprehensive technical documentation.
  • Additionally, they will be able to identify opportunities to improve process efficiency and safety, and support verification activities to ensure devices meet functional, safety, and performance specifications.
  • Key Responsibilities
  • Design and optimize neutron activation processes for holmium microspheres.
  • Lead and execute verification and validation protocols, ensuring alignment with technical specifications and regulatory standards.
  • Ensure compliance with regulatory standards such as ISO 13485, ISO 14971, FDA 21 CFR Part 820, and radiological safety requirements.
  • Conduct risk assessments and develop mitigation protocols for potential hazards.
  • Prepare and present comprehensive technical documentation, ensuring traceability and compliance with internal and regulatory requirements.
  • Identify opportunities to improve process efficiency and safety.
  • Support verification activities to ensure devices meet functional, safety, and performance specifications.
  • Participate in design validation to ensure product alignment with user needs.

Requirements

  • Bachelor's or Master's degree in Biomedical Engineering, Nuclear Engineering, Material Science, Medical Physics, or a related field.
  • 2-5 years of experience in medical device development, with a focus on verification and validation processes.
  • Experience with neutron activation or radioisotope production is a strong plus.
  • Proficiency in risk management processes and V&V tools.
  • Strong understanding of regulatory standards (ISO 13485, ISO 14971, FDA QSR).
  • Excellent communication, analytical, and problem-solving skills.
  • Familiarity with radiation safety protocols; Radiation Safety certification is a plus.
  • Ability to work effectively in cross-functional and multicultural teams.

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