Senior Design Assurance Engineer

1 week ago

Cambridge, Cambridgeshire, United Kingdom Sandoz UK & Ireland Full time £60,000 - £120,000 per year

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

Your Key Responsibilities
Your responsibilities include, but not limited to:

  • Provide expertise in a range of design assurance skills including : Risk management; HF/UE activities, verification and validation, internal auditing.
  • Act as senior DA Engineer within programs, providing strategic and technical oversight pertaining to DA Engineering
  • Provide support and development for junior colleagues, either within the project or standalone mentorship
  • Provide support to the group leader as required, to aid with the smooth running of the department
  • Lead initiatives to improve the efficiency and effectiveness of the group.
  • Lead or participate in design reviews
  • Specific program responsibilities e.g. risk management team leader, design history file owner etc.

Essential Requirements
What you'll bring to the role:

  • Masters, PhD, or university degree in the field of engineering, Quality, life sciences, or other relevant subject
  • Proven track record in development of medical devices (ideally in the field of drug delivery) 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
  • Proven ability to provide guidance and mentorship to junior engineers
  • High level of proficiency in multiple engineering areas: risk analysis (in line with ISO 14971); HF/UE, specification setting, Good Documentation Practice etc.
  • Results orientated, enthusiastic, and driven by excellence
  • Excellent command of English (verbal and written)
  • Experience of working within the ISO13485 medical devices quality framework and in depth knowledge of GMP, EU, and FDA regulatory requirements

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

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