Validation Engineer (Medical Device)

About the role

We are looking for a Validation Engineer to join a global leader in healthcare and medical technology. The role is embedded within a small QA team and works closely with software development groups to ensure compliance with medical device regulations throughout the product lifecycle. You will act as the bridge between engineering and quality, providing guidance on validation strategy and change control.

Key responsibilities

• Embed within medical device project teams to advise on validation processes and compliance pathways.
• Ensure software development follows the software validation system lifecycle and relevant medical device standards.
• Author, review and execute validation protocols, reports and technical documentation.
• Lead change‑control activities and provide guidance on validation changes in line with the QMS.
• Collaborate with the wider QA team to support audits, risk assessments and continuous improvement initiatives.

Required profile

• Experience working in a regulated environment, preferably medical devices under ISO 13485 or FDA 21 CFR Part 820.
• Proven background as a Validation Engineer with hands‑on experience writing validation protocols.
• Ability to provide practical, proactive guidance to R&D and project teams.
• Strong understanding of quality management system (QMS) procedures and change control.

Required skills

• ISO 13485
• FDA 21 CFR Part 820
• Validation protocol development
• Change control management
• Quality management system (QMS) procedures

What we offer

• 12‑month contract with potential for extension or permanent conversion.
• Salary £35,000‑£66,000 per annum, dependent on experience.
• On‑site role based in Witney, South East England.