Site Name: UK - Hertfordshire - Ware RD, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence
Posted Date: Oct 18 2024
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK.
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 will also 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.Effectively communicate your work to the wider development team and stakeholders.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: Friday 1st November 2024Please 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.
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.
#J-18808-Ljbffr