About 42T

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 Role

Providing comprehensive leadership for complex, multi-faceted medical device and life science development projects. Driving strategic and technical direction, leading client relationships, managing critical risks and guiding multi-disciplinary teams to deliver impactful solutions that align with client and business goals.

Main Duties/Key Responsibilities:

• Leading complex medical device and life sciences programmes from concept to production, within a consultancy environment.
• Leading multi-disciplinary project teams to deliver against client and company project objectives.
• Supporting colleagues in the application and development of their skills and experience, especially more junior members of the team.
• Managing project scope, budgets, timelines, resourcing and quality; delivering projects to agreed quality and scope to budgets agreed between 42T and the project client.
• Setting the direction for the programme and working with other colleagues to identify and solve the key technical issues.
• Taking a leading role when interacting with clients to build credibility and develop lasting relationships.
• Supporting business development opportunities, through networking and representing the company externally and leading or contributing to proposals.
• Planning and costing new projects and authoring project proposals, taking input from relevant colleagues and suppliers including subject matter experts and the Account Manager.
• Depending on your specific expertise, breadth of experience and interests, there will also be scope for contributions on a range of projects in other areas of the business.

About You

Essential:

• A technical degree in mechanical engineering, biomedical engineering, product design, physics or a similar technical subject, or equivalent experience.
• Significant track record in leading the design and development of medical devices/life sciences products, from concept to production, in a fast-paced product development consultancy or device R&D environment.
• Significant experience in complying with the regulatory requirements of medical devices, working within ISO 13485 and other equivalent regulations and requirements.
• Experience working in a fast-paced product development consultancy environment on medical device or IVD projects.
• Proven track record in the application and detailed understanding of key industry standards and regulations, and how they fit into the device development process including ISO 13485 or 21CFR Part 820, ISO 14971 Risk Management, IEC 62366 Usability / Human Factors Engineering, and MDR/IVDR or equivalent FDA regulations.
• Experience leading multidisciplinary teams including mechanical, electronics and software engineering, product design and usability (Human Factors Engineering) as part of the development process.
• Ability to explain complex technical concepts and analysis to a range of audiences from technical experts to non-technical clients.
• Ability to present technical subjects in a compelling way, identifying the implications and demonstrating the implications to clients.
• Ability to engage in strategic discussions and clearly present how project findings may influence the client's product strategy.
• Excellent verbal and written communication skills.
• A passion and talent for engineering, product development and creative problem solving.
• Flexible approach to changing work tasks.
• Motivated to produce high quality work.
• Attention to detail.