42 Technology is a successful and growing consultancy specialising in innovation, design and development. Our work with world-leading clients in a range of industries takes products and processes from ideas to reality. We have built a reputation for challenging the status quo and finding creative and pragmatic solutions to difficult technical problems.

Our employees love the variety and challenge of our work. We have a stimulating and open culture, an excellent team and a great location in the historic town of St Ives, close to Cambridge.


The opportunity

This opportunity would be great for an experienced Project Lead with passion, ability and a proven track record in Medical Device development wanting to make a difference. 42 Technology is a growing and friendly company of ~45 employees, working in a challenging and creative environment. We are growing our Medical Devices team to help our clients deliver the future of healthcare.

If working with world leading clients on innovative medical device design and development projects excites you, then this role is for you.


The role

We are looking for a Project Lead with a strong technical background who will create value for our clients by successfully leading projects that solve complex technical problems to support the development of new medical devices. You will lead multidisciplinary teams on projects in our healthcare sector. You will have the opportunity to contribute to a wide range of projects for other industries, whilst developing opportunities with new and existing clients.

We offer a competitive package including 28 days’ holiday (plus bank holidays), flexible working options, private healthcare, a company performance-related bonus and free lunches when in the office.


About you

Essential:

  • A passion and talent for engineering, product development and creative problem solving.
  • A technical degree in mechanical or electrical /electronics or software or biomedical engineering, product design or physics /chemistry.
  • A proven track record in leading design and development projects for medical devices or in vitro diagnostics (IVD), working within ISO 13485 or to the equivalent regulations and requirements of the FDA.
  • Deep technical expertise, together with experience in taking a hands-on role in the development of complex technical solutions for new products and processes.
  • Excellent communication skills, including being able to present technical subjects persuasively, and negotiate with suppliers and other stakeholders.
  • Experience of leading or managing cross-disciplinary work packages, and reviewing the work of other engineers, designers and technologists.

Desirable:

  • Experience in developing medical electrical equipment, surgical instruments/consumables, drug delivery or diagnostics products, leading projects across all phases, from concept, design & development, transfer to manufacturing, CE marking / regulatory approval and launch.
  • Experience in implementing the risk management processes of ISO 14971.
  • Knowledge or experience of medical software life cycle management to EN ISO 62304.
  • Knowledge and awareness of user needs and the wider clinical and commercial context.
  • Knowledge of assay chemistry / technology, materials biocompatibility and sterilisation processes.
  • Experience of planning and managing multi-phase medical device development programmes.
  • Experience of mentoring other engineers to help them achieve personal development goals.
  • A keen interest in promoting the company, developing client accounts, and gaining industry sector-specific experience.

Next steps

If you are excited by this opportunity and believe you have the skills and experience to succeed, get in touch and tell us why. You can reach us at careers@42t.com. Please also send us a copy of your CV and quote reference PL21.

Even if you don’t have exactly the background indicated, do contact us if this type of job is of interest – we may well have similar opportunities that you would be suited to.

A position at 42T is very much what you make of it

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