Design Assurance Engineer

Sandoz UK & Ireland; Cambridge; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading company in the pharmaceutical sector seeks a Design Assurance Engineer to ensure compliance with design control activities. The role involves collaboration with multi-disciplinary teams and requires a strong background in quality management and regulatory standards. Ideal candidates will have a degree in engineering or life sciences and experience in medical device development. Join us to shape the future of biosimilar and generic medicines.

Benefits

Competitive salary

Annual bonus

Pension scheme

Health insurance

24 days annual leave

Flexible working arrangements

Employee recognition scheme

Learning and development opportunities

Qualifications

• 3+ years in medical device development.
• Experience with ISO13485 and GMP standards.

Responsibilities

• Prepare design and development documentation.
• Interface with Quality Assurance for compliance.
• Lead design reviews and guide project teams.

Skills

Quality Management

Risk Management

Regulatory Compliance

Education

Masters

PhD

University degree in engineering

Job description

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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!

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 overall role of the Design Assurance Engineer is to ensure project compliance to relevant regulations and to external and internal standards for design control activities and project documents.

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.

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)

#Sandoz

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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