Technical Project Manager – Medical Devices

We are a friendly company of ~40 employees, working in a challenging and creative environment. We are looking for a high calibre project leader to help us continue our recent growth. The successful candidate will have a strong track record in delivery of engineering projects; they will be self-motivated, enthusiastic, technically excellent, business savvy and an effective communicator.

You will be a project manager with a strong technical background who creates value for our clients by successfully leading projects that solve complex technical problems to support the development of new products. You will manage and lead multidisciplinary teams on projects in our healthcare sector. Plus, you will have the opportunity to contribute to a wide range of projects for other industries, whilst developing opportunities with new and existing clients.

42 Technology has a very strong technical team, with expertise in complex mechanical and electromechanical systems, thermal and fluidic analysis, novel sensors and sensing systems and connected devices. We have particular strengths in developing creative solutions that generate valuable intellectual property (IP) for our clients, and in helping them strengthen their IP portfolio. Candidates must bring a similar depth of experience and strength in their technical domain, alongside exceptional project leadership. They must be a persuasive and confident communicator with both the client and the internal project team.

We offer a competitive package including 28 days’ holiday, private healthcare, a company performance-related bonus and when in the office free lunches!

You will have:

• A passion and talent for engineering, product development and creative problem solving.
• A strong technical degree in mechanical or electrical /electronics or software engineering, product design or physics /chemistry from a well-reputed institution.
• A proven track record in managing design and development projects for medical devices or in vitro diagnostics (IVD), working within ISO 13485 and risk management processes of ISO 14971, 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, engaging communication skills, being able to present technical subjects persuasively, and negotiate with suppliers and other stakeholders.
• Experience of leading and managing cross-disciplinary work packages, and reviewing the work of other engineers, designers and technologists.

Ideally, you will also have many of the following:

• Experience in developing medical electrical equipment, surgical instruments and consumables or diagnostics products, leading projects across all phases, from concept, design & development, transfer to manufacturing, CE marking / regulatory approval and launch.
• 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 managing and mentoring other engineers to help them achieve personal development goals.
• Experience of reporting to higher levels of management and assisting the business in its wider strategic aims.
• A keen interest in promoting the company, developing client accounts, and gaining industry sector-specific experience.

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