This Cambridgeshire based medical device consultancy have 35 years' experience coming up with innovative, award-winning designs for healthcare. Based in a pretty, rural village, boasting impressive labs, workshops and collaborative spaces, they are a team of around 100 diverse individuals. Working in a caring, collaborative and fun environment, there's a strong emphasis on work-life balance and genuine opportunities to grow and develop your career in a supportive environment.
Unlike some other consultancies, all their projects medical and healthcare focused and the whole process is managed in house from concept, right through to industrialisation. They are looking for an experienced Project Manager to be responsible for all aspects of development programmes, from proposal planning and budgeting through to product delivery.
For people with additional technical expertise, there will be the opportunity for more technical contribution; as an advisor, consultant or technical reviewer to projects.
Part time hours will be considered, at a minimum of 3 working days per week.
- Technical Degree
- Proven track record in the planning and delivery of a wide range of medical devices development projects, ideally with knowledge of at least one of the following markets:
- Drug delivery (injectables, inhalation or drug packaging)
- Surgical / critical care
- Diagnostics instrumentation
- In-depth experience of one or more phases of the product development process (i.e. concept through to industrialisation and manufacture)
- Understanding of industry standards including ISO 13485, 14971 and 21CFR Part 820
- Experience in managing multi-disciplinary technical project teams
- Capable of evaluating project risks
- Project planning and costing
- Experience in conducting risk assessments and COSHH assessments
- Confident and with a positive and engaging communication style
- Effective collaborator
- Willing to travel (potentially frequently) within the UK and overseas
Nice To Haves:
- Experience of technical file management and submission
- Able to support business development and / or sales
- Understanding of project management tools (MS Project, etc)
- Familiar with the requirements of IEC 62304 and/or IEC 62366
- Experience in technology and supplier assessment
- Structured and methodical problem solving; ability to conduct trade-off analyses
Get in touch for a confidential chat!