NATROX® Wound Care
R&D Engineer, United Kingdom
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About the Role
We are looking for an Engineer who wants to join a small wound care company, to support the R&D Team across different projects, contribute to the current and future devices.
This is a fixed term contract for 3 months (possible extension) and can be a UK home-based role after some initial time onsite for onboarding.
Responsibilities
- Review test data and write reports
- Provide regulatory input within R&D
- Support projects by coordinating with test houses and liasing with suppliers
- Ensure robust compliance with the Design Control, Process Control, and Risk Management principles
- Draft work instructions and Quality Assurance/DHF documents
- Create and edit labels of the product/s and IFUs
- Review and edit 2D drawings in SolidWorks
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Qualifications
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- Engineering background
- Experience in working with medical devices (or other regulated industries such as automotive or aerospace)
- Understanding the principles of creating and maintaining technical documentation, such as drawings, test protocols and reports
- Robust understanding of regulatory processes
- Experience with CAD software, preferably SolidWorks
- Team player mindset, with good communication skills and ability to collaborate within and across functions
- Familiarity with ISO 13485 standards, ISO 10993, FDA 21 CFR 820, ISO 14971, and Medical Device Regulation
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