Design Assurance Engineer

Job Description Summary

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

What you’ll bring to the role:

Essential Requirements:

• 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

 

Skills Desired

Cad Software, Circuit Design, Design Engineering, Design for Manufacturability (DFM), Fea (Finite Element Analysis), Mechanical Design, Mechanical Engineering, Npd (New Product Development), Product Design, Systems Design, User Research