Senior Process Engineer (Medical Devices)

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About us

The facility for the Manufacturing of Active Implants and Surgical Instruments (MAISI) is a suite of cleanrooms located at St Thomas Hospital, part of the School of Biomedical Engineering & Imaging Sciences at King's College London. MAISI is a dedicated sub-contract manufacturing facility, fully staffed and equipped to build advanced active implantable medical devices and surgical instruments for first-in-human safety studies. We enable funded research to achieve its full impact by supplying prototypes for clinical evaluation, accelerating translation for the future benefit of patients. More information: https://www.kcl.ac.uk/bmeis/our-centres/maisi

About the role

We are seeking a Senior Process Engineer to join our team in manufacturing novel medical devices.

This is an exciting opportunity for a proactive individual to bring their manufacturing expertise to this new facility for the production of active implantable medical devices and multi-modal surgical instruments.

The facility is in the process of being established. Working closely with the facility director, the post holder will lead the engineering team to finalise the qualification and validation of the process equipment, support the Quality team in establishing the facility procedures, and liaise with clients and project stakeholders to develop product profiles.

The post holder will be a leading member of the Medical Device manufacturing team at King's, bringing their expertise to create, and improve, the processes used to operate our cleanroom's state-of-the-art equipment.

The job requires a perfectionist with an innate need to get things right but the flexibility to work in a dynamic environment; the person fulfilling this position should have the ability to work in a steady, thorough, and deliberate manner, and possess the persistence necessary to see a job through to completion.

The post holder will be employed within the School of Biomedical Engineering and Imaging Sciences in the Faculty of Life Sciences & Medicine at King's College London. The successful applicant will be based on the St. Thomas' Hospital campus and will work within a controlled environment (Cleanroom).

This is a full-time post (35 hours per week on site), and you will, in the first instance, be offered a fixed term contract until 5th February 2026.

About You

To be successful in this role, we are looking for candidates to have the following skills and experience:

Essential criteria

1. Degree in Electrical, Mechanical, or related Engineering discipline, or equivalent professional experience/membership.
2. Minimum of 5 years of experience in medical device manufacturing and cleanroom operation.
3. Strong understanding of technical drawings (electro-mechanical or related) and technical documentation.
4. Familiarity with medical device regulations and quality system standards, such as ISO13485, 21 CFR 820, AIMD, and MDR.
5. Outstanding problem-solving skills to guide development teams and select suitable processes.
6. Ability to think creatively and innovatively while maintaining professional conduct.
7. Good interpersonal skills to develop and maintain effective working relationships.
8. Exceptional attention to detail, with a high level of concentration, assertiveness and focus.

Desirable criteria

1. Training in medical device development, validation, and scale-up.
2. Experience working with (or be part of) an academic research team or start-up.
3. Project management training or an accredited qualification.
4. Knowledge of cleanroom construction, design, and validation.
5. Knowledge of medical device sterilisation, including validation.

Downloading a copy of our Job Description

Full details of the role and the skills, knowledge and experience required can be found in the Job Description document, provided at the bottom of the next page after you click "Apply Now". This document will provide information of what criteria will be assessed at each stage of the recruitment process.

Further information

This post is subject to Occupational Health clearances.

We pride ourselves on being inclusive and welcoming. We embrace diversity and want everyone to feel that they belong and are connected to others in our community.

We are committed to working with our staff and unions on these and other issues, to continue to support our people and to develop a diverse and inclusive culture at King's.

We ask all candidates to submit a copy of their CV, and a supporting statement, detailing how they meet the essential criteria listed in the advert. If we receive a strong field of candidates, we may use the desirable criteria to choose our final shortlist, so please include your evidence against these where possible.

To find out how our managers review your application, please take a look at our ' How we Recruit ' pages.

Interviews are due to be held on the 22nd and 23rd of August 2024. Please indicate at the time of application if you are unavailable on those dates.

This role does not meet the requirements of the Home Office and therefore we are not able to offer sponsorship for candidates who require the right to work in the UK.