Principal Human Factors Engineer

Site Name: UK - Hertfordshire

• Ware RD, USA - Massachusetts

• Waltham, USA - Pennsylvania

• Upper Providence

Posted Date: Jun 25 2024

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Principal Human Factors Engineer

We are looking for an enthusiastic and experienced Human Factors Engineer to support the development of new drug device combination products. Do you enjoy a challenging role with the opportunity deliver robust products that improve the patient experience and can give them access to life changing medicines from the comfort of their own home?

The Human Factors Engineer is part of a dynamic and growing team that are key to delivering an expanding portfolio of injectable devices and more, used for pharma and vaccine drug products.

The role is ideally be based at GSK's R&D site in Ware, Hertfordshire UK. We would consider Upper Providence and Waltham, US locations.

In this role you will…

• Provide inputs for human centred design engineering for a range of projects across all phases of development

• You will effectively communicate your work to the wider development team and stakeholders.

• You will be involved in problem solving and utilisation of different strategies to support resolution of design, risk and regulatory challenges.

• Support the execution of early patient handling studies (formative 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 the external vendors and the Human factors Team

• Management of 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

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• 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 and expectations for medical devices/combination products.

• 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 e.g. global submissions, agency interactions and authoring dossiers

• Experience with integration of risk factors and user inputs into device design

Preferred Qualifications/ Experience

If you have the following characteristics, it would be a plus:

• Ability to analyse and summarise 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/organisational skills

• Evidence of team working skills and flexibility

• Experience with combination product and/or parenteral device development would be beneficial

Closing Date for Applications: Monday 8th July 2024

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

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 revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.

Find out more:

Our approach to R&D.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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 - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

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