Senior R&D Engineer, Device Usability

McDermott Laboratories Limited<p></p><p></p><p>At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.<br/><br/>Viatris empowers people worldwide to live healthier at every stage of life.<br/><br/>We do so via:  <br/><br/>Access – Providing high quality trusted medicines regardless of geography or circumstance;<br/>Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and  <br/>Partnership – Leveraging our collective expertise to connect people to products and services.  <br/> </p><p>Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.</p><p></p><p>For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.</p><p></p><p>The Role &amp; What You Will Be Doing</p><p>Development of Design Controls specifically relating to the User Interface of Drug-Device Combination Products. Working alongside UI team members to develop QMS-compliant User Interface deliverables across the Device Development portfolio. Driving User Interface (UI) team activities related to metric-driven continuous improvement of device user interface deliverables. Maintenance of Artwork Management (Instructions for Use, Device Labelling and Packaging) and Trade Dress processes within the User Interface team. Coordination, Shipment and Management of Human Factors study supplies.  </p><p></p><p>Every day, we rise to the challenge to make a difference and here’s how the Senior R&amp;D Engineer, Device Usability role will make an impact: </p><ul><li><p>Coordinate the UI team development of Usability/Human Factors processes and its integration into wider Global Device Development processes. Map the infrastructure of Standard Operating Procedures and Work Instructions and work with team to identify opportunities for development and ensure on-time delivery of periodic reviews.</p></li><li><p>Drive efficiency in all activities relating to usability / human factors through regular process reviews and implementation of lessons learned, utilizing the regular team forum to review and implement metric-driven program efficiencies.</p></li><li><p>Conduct document reviews to ensure that alignment is achieved and maintained across development programs and the Quality Management system at all times.</p></li><li><p>Conduct verification of Usability related technical content of device regulatory submissions (Health Authority and Notified Body).</p></li><li><p>Manage the Combination Product Trade Dress development and review on behalf of GDD; linking to Human Factors Engineers / Program Management / Design Engineers for input and reviews as appropriate.</p></li><li><p>Develop and maintain the User Interface teams Artwork management system; interface with regulatory labelling and regional artwork teams through the Change Control process.</p></li><li><p>Represent the UI team on Change Controls and QMS management.</p></li><li><p>Represent usability processes at internal and Health Authority / Notified Body audits and inspections.</p></li><li><p>Develop and monitor Key Performance Indicators for the team to track efficient delivery against program plans.</p></li><li><p>Coordination, Shipment and Management of supplies (device / packaging) for Human Factors studies / Health Authority samples. </p></li><li><p>Support post production activities related to the Combination Product User Interface and user Risk Management.</p></li></ul><p></p><p>About Your Skills &amp; Experience</p><p>For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:</p><ul><li><p>Degree or equivalent in a science/ engineering discipline</p></li><li><p>Execution of Design Control of Medical Devices / Combination Products through the application of ISO 13485 and 21CFR820.30</p></li><li><p>Demonstrable experience of the development and implementation of continuous improvement practices within a regulated framework.</p></li><li><p>Excellent verbal and written communication skills incl. technical report writing.</p></li><li><p>Ability to work on your own initiative, prioritize work and manage several projects simultaneously.</p></li><li><p>Enthusiastic, conscientious, highly driven and motivated team player.</p></li><li><p>Experience of key aspects of User Interface Development e.g. Device Design / Usability Engineering / User Research / Device Risk Management.</p></li><li>