Medical Device V&V Engineer — Neutron Activation

EPM Scientific; Nederland; Hybrid; EUR 60,000 - 80,000; Full time

Job summary

A leading science recruitment firm is seeking a Verification & Validation Engineer to ensure compliance and process integrity for medical devices involving neutron activation technologies. This hybrid role involves validating complex processes according to international standards. Key responsibilities include developing V&V plans, collaborating with QA/RA teams, and preparing reports for regulatory bodies. Candidates should have a relevant engineering degree and experience in medical device development, particularly with regulatory standards such as ISO 13485 and FDA requirements.

Qualifications

• Degree in Mechanical, Nuclear, Biomedical Engineering or related field.
• Experience in verification and validation within medical device development.
• Understanding of ISO 13485, ISO 14971, FDA 21 CFR Part 820 regulatory standards.

Responsibilities

• Develop and maintain V&V plans for neutron activation processes.
• Validate and optimise processes with nuclear facilities.
• Ensure compliance with regulatory verification and validation requirements.

Skills

V&V in medical devices

Regulatory standards knowledge

Documentation skills

Collaboration with QA/RA teams

Education

Bachelor's or Master's degree in Engineering

Job description

A leading science recruitment firm is seeking a Verification & Validation Engineer to ensure compliance and process integrity for medical devices involving neutron activation technologies. This hybrid role involves validating complex processes according to international standards. Key responsibilities include developing V&V plans, collaborating with QA/RA teams, and preparing reports for regulatory bodies. Candidates should have a relevant engineering degree and experience in medical device development, particularly with regulatory standards such as ISO 13485 and FDA requirements.