Development Engineer
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Development Engineer – Medical Devices
We are seeking a Development Engineer to join our team in the design and manufacture of silicone-based medical devices. This is a hands-on role and entails the creation and maintenance of Design History documentation for legacy and new devices, testing, protocols and reports as required and continuous improvement initiatives in a regulated environment.
Responsibilities:
- Maintain Design History Files (DHF) for new and legacy products.
- Conduct risk assessments, design reviews, and product testing.
- Support manufacturing with technical documentation, jigs/fixtures, and process improvements.
- Verification and Validation testing.
- Develop robust manufacturing and assembly processes.
- Collaborate with cross-functional teams and external evaluators.
- Assist with regulatory compliance and technical file maintenance.
Requirements:
- Degree in medical/mechanical engineering or equivalent.
- 1–2 years’ experience in medical device or regulated industry.
- Knowledge of ISO 13485, ISO 14971, and CAD software (OnShape, SolidWorks).
- Understanding of materials, moulding, extrusion, and sterile packaging.
- Strong attention to detail, communication skills, and a proactive mindset.
Job Type: Full-time
Location: Leeds
Salary: £32 - £36k
Benefits: 31days holiday
If you’re detail-oriented, proactive, and eager to contribute to meaningful innovation, we’d love to hear from you.
Apply now or message us to learn more!
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