Senior Engineer
Location: Cambridge (United Kingdom) (Sandoz)
Time Type: Full time
Job Description
Job Description Summary
Join us, help us make healthcare fairer and faster.Job Description
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:
Your responsibilities include, but not limited to:
• 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
What you’ll bring to the role:
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?
Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.
Our momentum 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 careers, where diversity of thought is welcomed and where personal growth is supported!
Join us, help us make healthcare fairer and faster.
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.
#Sandoz
Skills Desired
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