Randstad
Junior Software Engineer
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Junior Software Engineer
Position Type: 12-Month Initial Contract (With high potential for extensions or permanent conversion)
Salary: £40,000 - £50,000 per annum (Dependent on experience, entry level and seasoned professionals considered)
Location: Witney, on site full time
About the Role
We are seeking a Junior Software Engineer to join a global leader in healthcare and medical technology. In this role, you will be embedded within a highly collaborative team of 5 QA and engineering professionals, working side-by-side with the software development teams who write the code for our life-changing medical devices.
Your core mission is to act as the bridge between engineering and compliance. Rather than focusing on day-to-day manufacturing operations, this position is deeply embedded within R&D and project teams. You will ensure that software development teams strictly adhere to software validation system lifecycles and medical device regulatory standards, acting as a trusted consultant on validation strategy, change control activities, and protocol execution.
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Our team is diverse, ranging from ambitious engineers with 2–3 years of experience to industry veterans with over 20 years of expertise. We are looking for someone with a solid foundation in regulated environments who can provide practical, proactive guidance to keep our projects moving safely and compliantly.
Key Responsibilities
- Project Consultation & Strategy: Embed within medical device project teams to provide strategic guidance on validation processes, helping teams navigate compliance pathways smoothly.
- Lifecycle Compliance: Ensure software teams are fully complying with software validation system lifecycles and strict medical device requirements.
- Protocol Development: Author, review, and execute robust validation protocols, reports, and technical documentation to meet rigorous quality standards.
- Change Control Management: Provide expert guidance on validation changes and lead change control activities in accordance with established quality management system (QMS) procedures.
- General QA Support: Collaborate closely with the wider Quality Assurance team to support audits, risk assessments, and continuous improvement initiatives.
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What We Are Looking For
- Regulated Industry Experience: Experience working within a strictly regulated environment (highly prefer medical devices under ISO 13485 / FDA 21 CFR Part 820, though Pharmaceuticals or Aerospace will be considered).
- Validation Background: Proven track record as a Validation Engineer with direct experience writing validation protocols. (Note: You do not need to be a software or systems specialist, but a strong understanding of general validation principles is essential).
- Lifecycle & Change Control Knowledge: Solid understanding of validation system lifecycles and the impact of change control in a regulated manufacturing/design environment.
- Collaborative Communicator: Ability to confidently guide, advise, and consult with software developers and project stakeholders on compliance strategy.
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