Senior Device Engineer (Technical Documentation)
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape.
The Purpose Of The Role Is To:
* Provide end-to-end support for the design and development of drug delivery devices for Sandoz’s pipeline and portfolio of products
* Lead technical activities on projects in SDDC and support development of junior colleagues
Your Key Responsibilities:
* Drive excellence in the technical device design activities in SDDC:
* Oversee detailed design and assessments for components and systems from prototype stage to commercial tooling, for both in-house developments and third party supply
* Contribute to design for manufacture activities for components and devices and support the industrialisation of devices
* Liaise with suppliers to procure and optimise parts, such as moulded components
* Contribute to material review and selection for device components
* Lead preparation for and participate in Design Reviews
* Act as a key technical member of project teams, supporting the Device Project Leads with planning and the creation of technical documentation for Quality and Compliance requirements:
* Manage and lead technical Device Engineering project activities including planning, resourcing, monitoring progress and driving deliverables
* Lead creation of documents to support the DHF, such as Design Input Requirements and Design Output documents
* Participation in Risk Analysis activities, such as FMEAs
* Support the testing and characterisation of components and devices from early stage exploratory testing through to Design Verification Testing (DVT):
* Oversee the creation of test methods, protocols and reports
* Oversee the design, build and use of test rigs
* Oversee testing to understand performance, identify issues and analyse results
* Lead initiatives to improve the efficiency and effectiveness of the group
* Keep abreast of latest developments and training
* Demonstrate compliance with SDDC’s Quality Management System
* Reporting of technical complaints / adverse events
Essential Requirements:
* Masters, PhD, or university degree in the field of engineering, or other relevant subject
* English
* Proven track record (10+ years) in the design and development of medical devices and/or combination products within a pharmaceutical, medical devices, and/or combination products setting
* Extensive technical knowledge of medical device technology and drug-device combination products
* Extensive knowledge of manufacturing methods with a focus on injection moulded components from prototype to commercial scale manufacture
* High level of proficiency in multiple engineering areas: 3D CAD systems; preferably SolidWorks, risk analysis, tolerance analysis, mechanism design etc
* Experience and knowledge of analytical engineering activities, such as Tolerance Analysis
* Technical writing skills
* Proven ability to provide guidance and mentorship to junior colleagues
* Experience of working within the ISO13485 medical devices quality framework with a strong understanding of risk management
* Knowledge of assembly processes and good DFMA skills
* Results orientated, enthusiastic, and driven by excellence
You’ll Receive: Competitive salary, Annual bonus, Pension 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, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!
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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