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Viatris
The Role & What You Will Be Doing
Purpose of the role is to apply design and industrialisation expertise in the development of drug delivery devices, to develop the specification of components and assemblies and prepare the supporting design documentation to help ensure the programme teams achieve their delivery milestones.
Every day, we rise to the challenge to make a difference and here’s how the Senior Device Design Engineer role will make an impact:
Working in multi-disciplinary project teams to provide focused design input to support the development of a robust technical specification and functional design of combination products that meets performance and reliability requirements and design for commercial manufacture.
Creating, reviewing and updating detailed designs of component and assemblies of the combination products, including specifications, bill of materials, 3D CAD models and part and assembly drawings and packaging, and associated documentation for design controls.
Taking a lead in problem solving, identifying and mitigating risks within the design of combination products to help the team control and minimize use-related, design related, and process related risks.
Authoring, reviewing and verifying technical documents of the design history files for combination products as required for compliance with our Quality Management Systems requirements
Participating in design reviews, programme team meetings, and other deep-dive technical meetings to explain the design decisions and contribute with practical propositions to resolve technical issues and any emerging risks or concerns.
About Your Skills & Experience
For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
First or upper second degree in mechanical engineering, product design, or equivalent
Providing clear and authoritative explanations of development activities to both technical and non-technical specialist audiences.
Reviewing and delivering technical reports and producing high quality design documentation within a regulatory controlled GMP environment.
Strong time-management skills, resilience and resourcefulness, able to navigate multiple projects and changing priorities
Experience of all stages of the product development process, through to commercialization with good technical skills and broad knowledge of mechanical engineering principles
Desirable: Familiar and experienced with the principles of Design Control that will apply to your work within the context of ISO 13485 & FDA 21 CFR Part 820.
Being part of a dynamic fast paced team with good influencing skills and ability to think on your feet and be accountable for timely completion of your deliverables
Good 3D visualization and understanding of mechanism design and functional design
Familiarity with 3D CAD using Creo or SolidWorks
Experience in the design for manufacture, tooling, processing and industrialisation of high volume moulded parts and assemblies for medical or drug delivery applications
Experience of delivering product in cGMP environments
Bachelor's degree
