Principal Device Development Engineer

GlaxoSmithKline; Ware; Hybrid; GBP 45,000 - 65,000; Full time

Job summary

A leading global healthcare company is seeking an experienced engineer to support the development of innovative medical devices. This role involves technical leadership in in silico modelling and collaboration with multidisciplinary teams to overcome design and regulatory challenges. Candidates should possess a degree in a relevant field and experience in medical device development, particularly injectables or respiratory products. Flexible hybrid working is available at the Ware site in the UK.

Qualifications

• Proven experience in medical device or combination product development.
• Deep understanding of in silico modelling tools (e.g. CAD, FEA).
• Excellent time management and organizational skills.

Responsibilities

• Define and implement strategic approach to in silico modelling.
• Provide technical leadership within device development workstreams.
• Collaborate with cross-functional teams and resolve regulatory challenges.

Skills

In silico modelling

Problem-solving

Teamwork

Time management

Excellent communication

Education

Degree in Mechanical Engineering, Biomedical Engineering, or related field

Tools

MATLAB

CAD

FEA

CFD

Job description

We are looking for an experienced and motivated engineer with an 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. We value problem-solving skills, teamwork, and a passion for delivering high-quality solutions.

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives.

In this role you will:

• 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 which meet regulatory expectations.
• Collaborate with internal teams and external partners to resolve design, manufacturing, and regulatory challenges.
• Present project updates to senior leaders and supporting 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).

Why you?

Basic Qualifications

• Degree (or equivalent) in Mechanical Engineering, Biomedical Engineering, or a related field.
• Proven experience in medical device or combination product development, ideally in injectables and/or respiratory products.
• Deep understanding of in silico modelling tools and approaches (e.g. CAD, FEA, CFD/DEM, MATLAB)
• Excellent understanding of mechanical principles and systems.
• Able to communicate complex technical information to senior stakeholders effectively and concisely.
• Management of suppliers (e.g. external manufacturing suppliers, design consultancies).
• Excellent time management and organizational skills, managing multiple projects of varying complexity simultaneously.
• Ability to build strong relationships with internal and external stakeholders.

Preferred Qualification

• Experience of 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.

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.

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 (including family medical history), military service or any basis prohibited under federal, state or local law.