Principal Device Engineer

We are looking for an enthusiastic and experienced Development Engineer to oversee device workstreams for increasingly complex combination products. Do you enjoy a stimulating 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 Development Engineer is part of a dynamic and growing team that is 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.

In this role you will

• Lead device development work streams for R&D combination product development projects.
• Be accountable for compiling device development documentation including Design History Files (DHF) and Risk Management Files (RMF).
• Be responsible for authoring device parts of global submissions (e.g., technical file, BLA/MAA) and agency interactions.
• Work with project managers to manage device development budgets and resource plan.
• Use problem-solving skills and utilisation of different strategies to support resolution of design, manufacturing, and regulatory challenges.
• Collaborate with multi-disciplinary teams across GSK and international sub-contractors.
• Participate in device risk assessments (e.g., user, design, or process risk assessments)
• Lead design reviews at critical stages of device development.
• Co-ordinate testing activities (e.g., verification, validation, Design of Experiments, robustness studies) to ensure device safety and performance.
• Work closely with the manufacturing organisation to ensure that methods and processes are transferred for clinical and commercial production.
• Contribute towards continuous improvement activities to drive quality, efficiency, and consistency.

Closing Date for Applications: 27th June 2023 (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.

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 you?

Qualifications & Skills

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

• 1st or 2:1 in Mechanical Engineering, Biomedical Engineering or related degree
• Experience in leading medical device or combination product development programs
• Working experience in managing multiple projects of varying complexity simultaneously
• Proven ability to quickly establish relationships with internal and external stakeholders
• Strong understanding and experience working within 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.

Preferred Qualifications & Skills

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

• Drive to deliver results and continually improve
• People-orientated with solid presentation skills and excellent written and verbal communication skills
• Experience in the regulatory pathways for combination products
• Experience in human factors/usability engineering (IEC 62366)
• Strong time management/organisational skills
• Evidence of team working skills and flexibility

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 positively impact the health of 2.5 billion people by the end of 2030.

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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