Job Description Summary
Join our Sandoz Device Development team at Cambridge!
Job Description
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our ‘new’ Sandoz!
Your Key Responsibilities:
* Responsible for supporting Sandoz teams in the application of Human Factors/Usability Engineering (HF/UE) principles to the development of medical devices and drug/device combination products
* Provide graphic design support for the creation and implementation of user instructions, labelling and packaging
* Leading activities necessary for achieving (HF/UE) deliverables (user profile/ capabilities, known use problems, task analyses, threshold analyses etc.)
* Identifying and recording user interface requirements, including implementation and execution of early stage user studies
* Supporting risk management activities, including the identification of use-related hazards and the development of Use Related Risk Analysis (URRA)
* Manage/lead formative and summative evaluations together with external vendors
* Collaboration with Sandoz teams on the design and implementation of risk control measures
* Writing and reviewing technical HF/ UE documents in support of the Usability engineering file in-line with ISO 62366 and FDA guidance
What you’ll bring to the role:
Essential Requirements:
* University degree in the field of ergonomics and human factors, industrial/ product design or other relevant subject
* Proven track record (3+ years) as part of a medical device (UE/HF) team within a pharmaceutical, medical devices, and/or combination products setting
* Experience in design for print
* Comfortable writing technical documentation in support of the (UE/HF) file
* Understanding of the usability engineering process as per BS EN 62366 and the relevant FDA usability guidance documents
* Excellent command of English (verbal and written)
* Proficient in using Microsoft Word and Excel
* Proficient in the use of Adobe Illustrator and InDesign
You’ll receive:
Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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