Device Technology Manager, Insulin Drug Delivery (80-100% )
Inseriert am: 13.09.2019
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Job ID276592BRPosition TitleDevice Technology Manager, Insulin Drug Delivery (80-100%*)Apply to Job
Job Description
60 million! The number of people in the world with diabetes that take insulin. To meet this need, Novartis Sandoz has an ambitious goal to be a leader in biosimilar insulins. We are seeking a highly experienced design engineer with a detailed understanding of disposable and reusable insulin pens, as well as their final presentation as a combination product. The role involves working with external suppliers to develop best-in-class user-centric delivery devices that are verified and validated as a combination product. A high degree of collaboration with Novartis internal stakeholders and external partners will also be necessary.
Your responsibilities:
• Responsible for new product development of medical devices such as insulin pens as well as life-cycle management of marketed products
• Work cross-functionally to drive the innovation process, gaining design inputs from key stakeholders such as Marketing, Human Factors, Primary Packaging and Secondary Packaging, Production and Risk Management to ensure safe, reliable and intuitive to use products.
• Support transfer into manufacturing and subsequent life-cycle management including root-cause analysis of complaints and manufacturing issues, as well as design improvements using regulated change control processes
• Acts as a thought leader in design and disseminate knowledge and awareness within the wider organization, contributing to publications, presentations and patents
• Develop device concepts to support early phase development, and undertake detailed design of chosen architecture.
• Understand the injector pen patent landscape and support freedom-to-operate technical enquiries
• Oversight of third party suppliers to develop specific device components, get DfX inputs (moulding, assembly, testing), establish robust manufacturing process and map critical to quality design requirements to manufacturing controls
• Support the implementation of the control strategy for clinical trials and commercial production.
Minimum requirements
What you’ll bring to the role:
• Minimum: BS/MS or equivalent Desirable: Advanced degree in a scientific or relevant discipline (Ph.D. or equivalent).
• Fluent English (oral and written). Desirable knowledge of site language.
• 8-10+ years’ experience in designing insulin pens and having knowledge of combination product development and design history files
• Detailed knowledge of insulin pen features, competitor offerings and the patent landscape makes them an expert in this class of device.
• Understand all aspects of CAD design, especially plastic part design and manufacturing in low and high volumes (injection moulding and assembly). In addition, you should be an expert in tolerance analysis, integrating insulin cartridges into pens, dose accuracy and failsafe mechanisms.
• Experience in design verification and validation, as well as defining a control strategy to map critical-to-quality attributes into manufacturing process controls is essential.
• Detailed knowledge writing design history file documents are also required.
• Appreciation for the user and their challenges managing diabetes will be an advantage, as would experience of working within a pharma company and a matrix environment
• Detailed technical expertise in the following will be desirable:
• Understanding of patient therapy needs and current competitor product and patent landscape.
• Detailed knowledge of the technical challenges for the design and testing of insulin pens, as well as the interfaces to the primary pack and needle to ensure a robust combination product.
• Writing design control documentation and the application of systems engineering principles to define functions and interfaces for a combination product.
Why consider Novartis?
750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine
*Some restrictions on flexible working options may apply and will be discussed during interview if applicable.DivisionGlobal Drug DevelopmentBusiness UnitTECHNICAL R & D GDDLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegular
