Overview
We are looking for an experienced and motivated engineer with expertise in modelling to support the development of complex combination products. This role offers the chance to deliver innovative, patient‑centric devices that improve lives and enable access to life‑changing medicines. You will work in a collaborative environment with multidisciplinary teams, driving technical excellence and ensuring robust product development.
Responsibilities
* Define and implement a strategic approach to in‑silico modelling (FEA and fluids) to support the development and industrialisation of complex combination products, embedding modelling as a vital tool as part of the product development process.
* Provide technical leadership for in‑silico modelling within device development workstreams.
* Analyse complex multi‑phase technical problems, identifying tailored and cost‑effective in‑silico modelling approaches appropriate for the scenario.
* Collaborate with a cross‑functional team to design test programmes to demonstrate device robustness that meet regulatory expectations.
* Collaborate with internal teams and external partners to resolve design, manufacturing, and regulatory challenges.
* Present project updates to senior leaders and support design reviews at critical development stages.
* Drive continuous improvement initiatives to enhance modelling approaches, efficiency, and consistency.
* Contribute to the compilation and maintenance of device development documentation, including Design History Files (DHF) and Risk Management Files (RMF).
Basic Qualifications
* Degree (or equivalent) in Mechanical Engineering, Biomedical Engineering, or a related field.
* Deep understanding of in‑silico modelling tools and approaches (e.g., CAD, FEA, CFD/DEM, MATLAB).
* Proven experience in medical device or combination product development, ideally in injectables and/or respiratory products.
* Excellent understanding of mechanical principles and systems.
* Strong ability to communicate complex technical information to senior stakeholders effectively and concisely.
* Experience managing suppliers, including external manufacturing suppliers and design consultancies.
* Excellent time management and organisational skills, managing multiple projects of varying complexity simultaneously.
* Ability to build strong relationships with internal and external stakeholders.
Preferred Qualifications
* Experience leading device development matrix teams.
* Experience using explicit dynamic FEA software packages such as LS‑Dyna and/or Abaqus.
* Experience solving computational models using cloud‑based and/or HPC platforms.
* Knowledge of design of experiments (DOEs) and design space studies.
* Knowledge of regulatory requirements and industry standards, such as design controls (21 CFR 820.30), EU MDR 2017/745, ISO 14971, ISO 13485, and GMP.
* Authoring of global regulatory submissions and supporting agency interactions (e.g., FDA/EMA/notified bodies).
* Evidence of teamwork, flexibility, and a drive to deliver results.
* Familiarity with plastic injection moulding and device manufacturing processes.
Location
This role is based in the United Kingdom at GSK’s R&D site in Ware, Hertfordshire. Flexible hybrid working is available, with occasional travel required.
Application Deadline
Closing Date for Applications: 14th November 2025
Why GSK
Uniting science, technology and talent to get ahead of disease together.
Equal Opportunity Employer
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.
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