Senior Design Assurance Engineer

Sandoz UK & Ireland; Cambridge; On-site; GBP 45,000 - 65,000; Full time

Job summary

Sandoz UK & Ireland is seeking a Design Assurance Engineer to provide expertise in design assurance and lead initiatives in a transformative environment. The role involves mentoring junior engineers and ensuring compliance with regulatory standards in medical device development. Join a pioneering company committed to diversity and inclusion, and make a significant impact in the pharmaceutical industry.

Benefits

Competitive salary

Annual bonus

Pension scheme

Health insurance

Flexible working arrangements

Learning and development opportunities

Qualifications

• Proven track record in development of medical devices.
• Experience with ISO13485 and GMP regulations.
• Excellent command of English, both verbal and written.

Responsibilities

• Provide expertise in design assurance skills.
• Lead initiatives to improve efficiency.
• Support and develop junior colleagues.

Skills

Risk management

Verification and validation

Mentorship

Technical oversight

Documentation Practice

Education

Masters or PhD in Engineering, Quality, Life Sciences

Job description

1 day ago Be among the first 25 applicants

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:

• 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, and 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.

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 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
• 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 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)

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Design and Quality Assurance

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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