Senior Human Factors Engineer

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

Job summary

A leading company in the pharmaceutical industry seeks a Human Factors Engineer to support the development of medical devices and drug/device combination products. The role involves leading usability engineering activities, mentoring team members, and ensuring compliance with regulatory standards. Candidates should possess a Master's or PhD in a relevant field and have extensive experience in the medical device sector.

Benefits

Competitive salary

Annual bonus

Pension scheme

Health insurance

24 days annual leave

Flexible working arrangements

Employee recognition scheme

Learning and development opportunities

Qualifications

• 7+ years in medical device development or combination products.
• Technical knowledge of medical device technology.
• Experience within ISO13485 quality framework.

Responsibilities

• Lead HF/UE deliverables and ensure project tasks are fulfilled.
• Mentor junior team members and contribute to HFE strategies.
• Conduct user studies and manage risk analysis.

Skills

Human Factors Engineering

Usability Engineering

Risk Management

Problem Solving

Education

Masters or PhD in Industrial Design or Human Factors Engineering

Job description

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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!

Role Summary:

Responsible for supporting SDDC teams in the application of Human Factors/Usability Engineering (HF/UE) principles to the development of medical devices and drug/device combination products.

Your responsibilities include, but are not limited to:

• Lead activities necessary for achieving (HF/UE) deliverables (user profile/ capabilities, known use problems, task analyses, threshold analyses etc.).
• Ensure on time fulfilment of all project tasks.
• Assist in shaping Human Factors Engineering (HFE) strategies for the development of drug/device combination products.
• Use HFE experience to mentor and support more junior members of the team.
• Contribute to the strategic HFE strategies relating to projects.
• Identification and recording of user interface requirements, including implementation and execution of early-stage user studies.
• Support risk management activities, including the identification of use-related hazards and the development of Use Related Risk Analysis (URRA).
• Manage/lead formative and summative evaluations together with external vendors.
• Communicate effectively across all relevant organizational interfaces.
• Develop labelling and instructional materials in collaboration with design teams.
• Collaboration with SDDC teams on the design and implementation of risk control measures.
• Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt.

What you’ll bring to the role:

• Masters, PhD, or university degree in the field of industrial design, Human Factors engineering, engineering, or another relevant subject.
• Proven track record (7+ years) in development of medical devices and /or combination products within a pharmaceutical, medical devices, and/or combination products setting,
• Technical knowledge of medical device technology and drug-device combination products.
• An understanding of the Usability Engineering process outlined in BS EN 62366 and associated FDA guidance documents.
• Experience of working within the ISO13485 medical devices quality framework.
• Extensive technical knowledge of human factors and usability engineering processes in the context of medical devices and/or drug-device combination products.
• High level of proficiency in multiple areas of HF: knowledge of relevant standards; risk management; measuring patient awareness and preference; running HF studies.
• Results orientated, enthusiastic, and driven by excellence.
• Excellent command of English (verbal and written).
• Good problem-solving skills.

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!

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.

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, Engineering, and Research

• Industries

  Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research

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