Validation and Verification Engineer

ppWe are seeking a bVerification Validation (VV) Engineer /b 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. /p h3Location /h3 pOverijssel, Netherlands (Hybrid) /p h3Start Date /h3 pASAP /p h3Key Responsibilities /h3 ul libVerification Validation: /b Develop, execute, and maintain VV 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. /li libProcess Compliance Optimisation: /b 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. /li libRegulatory Coordination: /b Collaborate with QA/RA teams to meet all regulatory verification and validation requirements and close Change Control Processes (CCP). /li libDesign Validation: /b Participate in verification and design validation activities for device components, ensuring performance requirements and user needs are met. /li libDocumentation Reporting: /b Prepare comprehensive reports and present findings to internal stakeholders and external regulatory bodies. /li /ul h3Qualifications /h3 ul liBachelor's or Master's degree in Engineering (Mechanical, Nuclear, Biomedical, or related field). /li liProven experience in VV within medical device development. /li liStrong understanding of regulatory standards: ISO 13485, ISO 14971, FDA 21 CFR Part 820. /li liFamiliarity with radiological safety guidelines and reactor-based processes. /li liExcellent documentation and compliance skills. /li /ul h3Preferred Experience /h3 ul liHands-on experience with process validation and change control in a regulated environment. /li liKnowledge of neutron activation technologies and associated safety standards. /li liExperience managing CAPAs and risk mitigation strategies. /li /ul /p #J-18808-Ljbffr