Validation and Verification Engineer
About the Role:
We are seeking a Verification & Validation (V&V) Engineer to ensure compliance and process integrity for medical devices involving neutron activation technologies. This role focuses on validating complex processes within a regulated environment, ensuring adherence to international standards and supporting product performance requirements. You will work closely with specialised nuclear facilities and multidisciplinary teams to ensure robust and efficient activation processes.
Key Responsibilities:
- Verification & Validation Leadership:
- Develop, execute, and maintain V&V plans, Validation Master Plans (VMPs), protocols, and reports for neutron activation processes.
- Ensure full traceability and compliance with ISO 13485, ISO 14971, FDA 21 CFR Part 820, and radiological safety guidelines.
- Process Compliance & Optimisation:
- Validate and optimise neutron activation processes in collaboration with specialised nuclear research reactors and irradiation facilities.
- Identify and implement CAPAs to improve efficiency and minimise risks.
- Regulatory Coordination:
- Collaborate with QA/RA teams to meet all regulatory verification and validation requirements and close Change Control Processes (CCP).
- Design Validation:
- Participate in verification and design validation activities for device components, ensuring performance requirements and user needs are met.
- Documentation & Reporting:
- Prepare comprehensive reports and present findings to internal stakeholders and external regulatory bodies.
Qualifications:
- Bachelor's or Master's degree in Engineering (Mechanical, Nuclear, Biomedical, or related field).
- Proven experience in V&V within medical device development.
- Strong understanding of regulatory standards: ISO 13485, ISO 14971, FDA 21 CFR Part 820.
- Familiarity with radiological safety guidelines and reactor-based processes.
- Excellent documentation and compliance skills.
Preferred Experience:
- Hands-on experience with process validation and change control in a regulated environment.
- Knowledge of neutron activation technologies and associated safety standards.
- Experience managing CAPAs and risk mitigation strategies.
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