Design Assurance Engineer

Job Description Summary

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our ‘new’ Sandoz!
The Design Assurance Engineer ensures project compliance to relevant regulations and to external and internal standards for design control activities and project documents.

Job Description

The Design Assurance Engineer ensures 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 activities 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 working within the ISO13485 medical devices quality framework and in-depth knowledge of GMP, EU, and FDA regulatory requirements

• Experience 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, Share 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, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art 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 and entrepreneurial spirit 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 encouraged! 

The future is ours to shape!

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)

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Skills Desired

Cad Software, Creo Elements/Pro, Electrical Design, Geometric Dimensioning And Tolerancing (GD&T), Mechanical Design, Product Design, PTC Creo