Human Factors Engineer for Combination Products
4 weeks ago
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:
- Provide human-centered design engineering inputs for a range of projects across all phases of development.
- Effectively communicate work to the wider development team and stakeholders.
- Be involved in problem-solving and utilization of different strategies to support 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 related degree.
- Practical experience and knowledge of human factors and usability regulatory framework, 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.
Preferred Qualifications:
- Ability to analyze and summarize data and translate them into devices/combination products design recommendations.
- An 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.
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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