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Design Assurance Engineer

Sandoz UK & IrelandCambridge, England, United Kingdom

9 days ago

Job type

Full-time

Job description

Join to apply for the Design Assurance Engineer role at Sandoz UK & Ireland

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Join to apply for the Design Assurance Engineer role at Sandoz UK & Ireland

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.

Job Description

Your Key Responsibilities

Your responsibilities include, but not limited to :

Prepare medical device and drug / device combination product design and development documentation and compilation of Design History Files and / or Technical Files in collaboration with multi-disciplinary project teams
Interface with Quality Assurance functions to ensure compliance with company QMS and international standards and regulations
Guide and / or support project teams through design assurance and compliance activites and ensure best practices
Participate in and / or lead design reviews
Prepare medical device and drug / device combination product risk management documentation

Essential Requirements

What you’ll bring to the role :

Masters, PhD, or university degree in the field of engineering, quality management, life sciences, or other relevant subject

Good working knowledge of medical device and drug-device combination product development processes including design verification.

Proven track record (3+ years) as part of a medical device development team within a pharmaceutical, medical devices, and / or combination products setting

Experience of working within the ISO13485 medical devices quality framework and in depth knowledge of GMP, EU, and FDA regulatory requirements

Experience of working with ISO14971 risk management for medical devices

Clear thinker, who can work independently and as part of a matrix team structure

Ability to take ownership of initiatives, deliver results and strive for continuous improvement

Results orientated, enthusiastic, and driven by excellence

Excellent command of English (verbal and written)

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!

With investments in new development capabilities, 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 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 supported!

Join us!

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

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing

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Design Engineer • Cambridge, England, United Kingdom