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Principal Human Factors Engineer 360729

We are looking for an enthusiastic and experienced Principal Human Factors Engineer to support the development of new drug device combination products. Do you enjoy a challenging role with the opportunity to 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 including but not limited to injectable devices.

The primary location for this role GSK’s R&D site in Ware, Hertfordshire (UK) and can offer flexible hybrid working. Other possible locations include Upper Providence and Boston area in US. Occasional travel may also be required.

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.
• Manage and support the execution of early patient handling studies, identification and maintenance of user needs, conduct user related risk assessments,
• Plan and support the execution of design validation studies
• Ensure user needs are considered early and continuously throughout the design process
• Manage the interface between the external vendors and the Human factors Team
• Manage the development and population of the Design History File as it pertains to design Validation
• Be responsible for the authoring sections of regulatory files

Closing Date for Applications: Tuesday 14th February 2023 (COB)

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.
• Understanding of human factors and usability regulatory framework, including FDA guidance, IEC 62366 and ANSI/AAMI HE75 and expectations for medical devices/combination products.
• Experience of 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
• Experience with executing early and late human factors studies
• Ability to manage multiple projects

Preferred Qualifications & Skills:

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
• Strong time management/organisational skills
• Performance driven, driving for results and success with a sense of urgency
• Evidence of team working skills and flexibility
• Excellent written and verbal communication skills
• Great attention to detail

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.

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

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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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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.

Find out more:

Annual Report 2021

We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

Find out more:

Our approach to R&D

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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