Team Consulting is an award-winning device design and development consultancy. We are an Employee-Owned Trust solely focused on supporting our international clients in the field of medical device and healthcare products. You will work in our high-tech labs and workshops which are set alongside our 13th Century barn, just outside of Cambridge, 5 mins from the M11.
From large pharma companies, to start-ups, our clients come to us for all stages of medical device development. By combining our expertise and experience in design, engineering and human factors, we help our clients develop medical devices from early concept through to commercial launch.
We are looking for a Project Manager with the majority of their experience in drug delivery. You will be responsible for all aspects of our healthcare development programmes, from proposal planning activity to the budgeting stage, through to product delivery. The focus of this role is to ensure the projects delivered meet our clients' needs and Team's commercial expectations.
Depending on the specific expertise of the project manager, there will also be an opportunity for technical contribution, as an advisor, consultant or technical reviewer to projects.
What we need from you:
- a proven track record in the planning, control and delivery of a broad range of healthcare development projects predominantly drug delivery (injectables, inhalation or drug packaging)
- in-depth experience of one or more phases of the product development process (i.e. from concept through to industrialisation and manufacture)
- application and understanding of the requirements of key industry standards including ISO 13485, 14971 and 21CFR Part 820
- capable of contributing to proposal preparation activity including:
- evaluation of project risks
- project planning and costing
- experience in managing multi-disciplinary project teams (e.g. combining one or more of the following disciplines: mechanical engineering, electronics, software, industrial design, usability / human factors, device testing)
- experience in conducting Environment, Health & Safety risk assessments and COSHH assessments as part of project activities
- honours degree (or equivalent qualification / experience) in Science, Design or Engineering
Desirable
- experience in consultancy
- experience of technical file management and submission
- support for business development and / or sales activities
- understanding of project management tools (e.g. MS Project)
- familiar with the requirements of IEC 62304 and/or IEC 62366
Equal opportunities:
Team values equality, diversity and inclusion in employment and recruitment. We are committed to promoting equal opportunities and an inclusive community, where our talented people respect and value the contributions, skills, and abilities of others.
We want our people to succeed on merit, treating individuals equally, including making decisions and providing encouragement and opportunities relating to recruitment, career development and retention in a fair and consistent manner.
Our aim is a workplace free from all forms of bullying, harassment or victimisation, and unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.