Senior Device Design Engineer

Mylan Pharma UK Limited Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Our Global Device Development is an innovative, technically-excellent and fully integrated organization, delivering access to high quality, safe, robust and effective device and combination products to meet the worlds' evolving patient healthcare needs. We develop device technologies to enable drug-delivery for respiratory, biologic, biosimilar and injectable products, and work across Viatris to support innovative technology solutions to provide healthcare solutions for our patients.

We operate from 4 sites: Dublin, Ireland, Cambridge & Sandwich, UK and Southpointe, Pittsburgh, USA. Every member of our team is dedicated to creating better health for a better world, one person at a time. This position will lead assigned programs within the DDI portfolio stream, including complex injectables and feasibility projects, ensuring successful delivery against agreed objectives and key milestones such as Design Reviews and Regulatory Submissions, whilst leading the end-to-end management of device design (medical device, combination product including all packaging and labelling) and associated documentation.

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.

The Role & What You Will Be Doing

• Ensure clear prioritisation of project deliverables in alignment with Viatris, Global R&D and GDD strategic objectives.
• Drive a \"right first time\" approach to high-quality submissions, ensuring timely delivery of DHF documentation and submission packages while embedding continuous improvement to enhance content quality and reduce review cycle iterations.
• Maintain full compliance with procedural standards and QMS training requirements, championing best practices in documentation management, traceability, a single source of truth, and secure handling of documents across internal and external stakeholders.
• Possess a strong Design Engineering/Product Development background with a naturally inquisitive mindset focused on understanding problems deeply and developing effective, innovative solutions, translating stakeholder needs into design requirements and identifying technical challenges, risks and design optimisation opportunities.
• Lead the development of combination products from concept through to design transfer, leveraging engineering analysis and problem-solving methodologies such as root cause analysis, hand calculations, CFD, FEA and tolerance analysis.
• Demonstrate advanced proficiency in CAD design, including the creation of fully dimensioned 2D technical drawings and specifications, applying GD&T principles to ensure designs are robust, manufacturable and compliant with industry standards.
• Develop and evaluate prototype components and devices through hands-on testing, functional verification and performance analysis, using data-driven insights to refine and improve designs.
• Proactively identify, assess and mitigate technical risks in accordance with ISO 14971, ensuring appropriate risk controls are implemented and maintained throughout the product lifecycle, with a strong understanding of risk management techniques such as FMEA and FTA.
• Represent the Device Design & Industrialisation function within cross-functional program teams, supporting effective planning and execution of design and development activities.
• Ensure full compliance with Quality Management Systems (ISO 13485) by generating, reviewing and approving high-quality technical documentation, including DHF deliverables such as drawings, specifications, change controls, dFMEAs, risk management files, BOMs, CAD models and technical reports.
• Maintain high standards of technical documentation writing, ensuring clarity, accuracy and compliance with internal procedures and regulatory expectations, with willingness to travel regularly between Dublin, Cambridge and Sandwich sites and occasionally internationally as required.

About Your Skills & Experience

For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experien