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Senior Verification and Validation Engineer
1 maand geleden
We are seeking a highly skilled Verification and Validation Engineer to join our team at NonStop Consulting. As a key member of our team, you will be responsible for developing and optimizing neutron activation processes for holmium microspheres, while also supporting broader verification and validation activities for medical devices.
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.
This is a unique opportunity to contribute to cutting-edge medical technologies, ensuring they meet the highest quality standards and improve patient outcomes.
