Job Description Summary
You will support Sustaining Engineering activities for medical devices. Performing hands-on testing in optimisation of the device, conduct process development activities to understand process inputs and outputs.
About Us
We are a global medical technology company dedicated to advancing the world of health. Our Purpose is to make the impossible possible by transforming solutions that turn dreams into possibilities.
You will have the opportunity to help shape the trajectory of our company while leaving a legacy at the same time. We welcome people with the imagination and drive to help us reinvent the future of health.
Main Responsibilities
* Designs, develops and implements product and process improvements of a medical device, translating intangible design inputs into tangible engineering specifications and drawings.
* Select appropriate materials, processes and vendors to achieve the design and challenge these designs against design specifications, clinical use scenarios and international standards.
* Plans, coordinates and builds test parts for engineering evaluation, pre-clinical studies and clinical studies.
* Makes and presents engineering decisions.
In this role, you will work closely with R&D, Quality, Operations, and Regulatory Affairs teams to ensure systems align with all internal and external guidelines. You will also participate in creating and controlling project budgets and lead design, process root cause analysis, and support non-conforming product and complaint investigations.
To be successful in this role, you will need to have a Relevant Bachelor's Degree in Mechanical or Biomedical Engineering, 5+ Years of Experience and proven track record in a similar role, and experience within the Regulation Requirements (FDA/MDD/MDR).