Site Name: UK - Hertfordshire - Ware RD Posted Date: Nov 1 2024 407742 Principal Device Development Engineer / Device Project Lead We are looking for an enthusiastic and experienced Engineer to lead device workstreams for increasingly complex 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 Engineer is part of a dynamic and growing team that are key to delivering an expanding portfolio of injectable devices. The role is to be based at GSK’s R&D site in Ware, Hertfordshire (UK) and can offer flexible hybrid working. Occasional travel may also be required. 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 In this role you will Lead a device development matrix team for R&D combination product development projects, accountable for the compilation of device development documentation including Design History Files (DHF) and Risk Management Files (RMF). Use problem solving skills and utilisation of different strategies to support resolution of design, manufacturing and regulatory challenges. Present project status to senior leaders for endorsement at GSK governance forums and lead design reviews at critical stages of device development. Collaborate with multi-disciplinary teams across GSK and international sub-contractors. Be responsible for authoring device parts of global submissions (e.g. technical file, BLA / MAA) and agency interactions. Contribute towards continuous improvement activities to drive quality, efficiency and consistency. Why you? Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: BSc or MSc in Mechanical Engineering, Biomedical Engineering or related degree with strong academic performance Experience in developing devices within in the medical device or pharmaceutical industry Expert knowledge of device regulatory requirements and industry processes such as design controls (21 CFR 820.30), EU MDR 2017/745, risk management (ISO 14971), QMS (ISO 13485) and GMP. Experience in leading medical device or combination product development programs. Working experience of managing multiple of projects of varying complexity simultaneously. Proven ability to quickly establish relationships with internal and external stakeholders Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: Experience of human factors / usability engineering (IEC 62366) Drive to deliver results and continually improve. People orientated with strong communication and presentation skills. Excellent written and verbal communication skills Strong time management / organisational skills Evidence of team working skills and flexibility Closing Date for Applications – November 17th , 2024 (COB) 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). 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 Ukdiversity.recruitment@gsk.com or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive 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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