Human Factors Engineer for Combination Products

4 weeks ago


Ware, Hertfordshire, United Kingdom GlaxoSmithKline Full time
Job Description

We are seeking a highly skilled Human Factors Engineer to join our team in supporting the development of new drug-device combination products. The ideal candidate will have a strong background in human factors and usability, with experience in regulatory frameworks and design validation.

Key Responsibilities:

  1. Provide human-centered design engineering inputs for a range of projects across all phases of development.
  2. Effectively communicate work to the wider development team and stakeholders.
  3. Be involved in problem-solving and utilization of different strategies to support resolution of design, risk, and regulatory challenges.
  4. 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.
  5. Ensure user needs are considered early and continuously throughout the design process.
  6. Support the interface between external vendors and the Human Factors Team.
  7. Manage external HF vendors to ensure development activities align with GSK expectations.
  8. Support the development and population of the Design History File as it pertains to design validation.
  9. Author sections of regulatory files.

Requirements:

  1. Graduate in Mechanical Engineering, Biomedical Engineering, or related degree.
  2. Practical experience and knowledge of human factors and usability regulatory framework, including FDA guidance, IEC 62366, and ANSI/AAMI HE75.
  3. Experience on the development, manufacture, and integration of end-user inputs (user needs and risk-related scenarios) of medical devices/combination products.
  4. Working experience in product development and design validation as well as in the regulatory pathways for combination products is desirable.

Preferred Qualifications:

  1. Ability to analyze and summarize data and translate them into devices/combination products design recommendations.
  2. An understanding of the principles of design for manufacture.
  3. Excellent written and verbal communication skills as well as great attention to detail.
  4. Strong time management/organizational skills.
  5. Evidence of team working skills and flexibility.

About GSK:

GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns.

We believe in an agile working culture for all our roles.



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