Senior Design Assurance Engineer

Sandoz International GmbH; Cambridge; Hybrid; GBP 45,000 - 85,000; Full time

Job summary

An established industry player is seeking a senior Design Assurance Engineer to lead and mentor within a dynamic team. This role involves providing strategic oversight in design assurance, enhancing efficiency, and supporting the development of junior engineers. With a focus on medical devices and drug delivery systems, you will play a pivotal role in ensuring compliance with industry standards and regulations. Join a company committed to innovation, diversity, and personal growth, where your contributions can make a real impact on patient care and access to high-quality medicines. This is an exciting opportunity to shape the future of healthcare.

Benefits

Competitive salary

Annual bonus

Pension scheme

Share scheme

Health insurance

24 days annual leave

Flexible working arrangements

Employee recognition scheme

Learning and development opportunities

Qualifications

• Proven track record in medical device development, especially drug delivery.
• Extensive technical knowledge of drug-device combination products.

Responsibilities

• Provide design assurance expertise and support junior colleagues.
• Lead initiatives to improve group efficiency and effectiveness.

Skills

Risk management

Human Factors/User Experience (HF/UE)

Verification and validation

Internal auditing

Mentorship

Results orientation

Excellent command of English

Education

Masters or PhD in Engineering

University degree in Quality or Life Sciences

Tools

ISO 14971

ISO 13485

GMP

EU and FDA regulatory requirements

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.

Your Key Responsibilities:

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

What you’ll bring to the role:

1. Masters, PhD, or university degree in the field of engineering, Quality, life sciences, or other relevant subject.
2. Proven track record in the 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.
3. Extensive technical knowledge of medical device technology and drug-device combination products.
4. Proven ability to provide guidance and mentorship to junior engineers.
5. High level of proficiency in multiple engineering areas: risk analysis (in line with ISO 14971); HF/UE, specification setting, Good Documentation Practice etc.
6. Results-orientated, enthusiastic, and driven by excellence.
7. Excellent command of English (verbal and written).
8. Experience 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, 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)

This site is intended for a global audience.