Date Posted: Friday 25 September 2020
You will work within a dynamic, multidisciplinary team to optimise the product design, tackling challenging engineering problems and generating novel solutions, using direct input from clinicians. Working closely with QA/RA, you will lead the navigation of the product development process to prepare the technical file for a First-In-Human trial. Your exceptional communication skills and ability to build strong working relationships will allow you to manage problems and develop solutions that deliver results. The ideal candidate will have product and process development experience in the medical device sector with Class II and/or III devices.
Your Experience / Skills
7+ years - Job can be tailored to experience
- Minimum 5 years of relevant engineering/ design experience in the medical device sector.
- Strong understanding of ISO 13485 and FDA quality system regulations, with a direct experience of navigating the an R&D stage gate process for Class II or higher medical devices.
- Knowledge of relevant medical device standards (e.g. electrical safety, usability, etc.).
- Practical knowledge of manufacturing processes including injection moulding, extrusion, assembly methods and design for manufacture methodologies for catheter technologies.
- Proficient in SOLIDWORKS 3D CAD.