Human Factors Engineer

3 weeks ago

Hertfordshire, United Kingdom GlaxoSmithKline Full time
Job Title: Principal Human Factors Engineer

We are seeking a highly skilled Principal Human Factors Engineer to join our team at GlaxoSmithKline. As a key member of our design team, you will be responsible for ensuring that our medical devices and combination products meet the highest standards of usability and safety.

Key Responsibilities:
  • Provide human-centered design engineering inputs for a range of projects across all phases of development.
  • Effectively communicate your work to the wider development team and stakeholders.
  • Contribute to problem-solving and the utilization of different strategies to support the resolution of design, risk, and regulatory challenges.
  • Support the execution of early patient handling studies, identification and maintenance of user needs, conducting user-related risk assessments, planning and execution of design validation activities.
  • Ensure user needs are considered early and continuously throughout the design process.
  • Support the interface between external vendors and the Human Factors Team.
  • Manage external HF vendors to ensure development activities align with GSK expectations.
  • Support the development and population of the Design History File as it pertains to design validation.
  • Author sections of regulatory files.
Requirements:
  • Graduate in Mechanical Engineering, Biomedical Engineering, or a related degree.
  • Practical experience and knowledge of human factors and usability regulatory frameworks, including FDA guidance, IEC 62366, and ANSI/AAMI HE75.
  • Experience on the development, manufacture, and integration of end-user inputs (user needs and risk-related scenarios) of medical devices/combination products.
  • Working experience in product development and design validation, as well as in the regulatory pathways for combination products, is desirable.
  • Experience with integration of risk factors and user inputs into device design.
Preferred Qualifications:
  • Ability to analyze and summarize data and translate them into device/combination product design recommendations.
  • Understanding of the principles of design for manufacture.
  • Excellent written and verbal communication skills, as well as great attention to detail.
  • Strong time management/organizational skills.
  • Evidence of team working skills and flexibility.
  • Experience with combination product and/or parenteral device development would be beneficial.

We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programs, pension plan membership, and shares and savings programs. We also offer a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology, and disease mechanisms, and transform medical discovery.

We are an equal opportunities employer and welcome applications from all qualified candidates. If you share our ambition, join us at this exciting moment in our journey to get ahead together.

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