An impressive list of perks and benefits awaits the successful Device Test Manager who joins this wonderful, award-winning Medical Devices consultancy, based in Cambridge. Not only that, but they are set in a beautiful village location, in stunning, well-equipped facilities.
More on that in a minute, but let me tell you a bit about the job first…
- Working exclusively on medical devices, manage and encourage the ongoing development of device technicians, nurturing their skillsets and expertise
- Identifying which key resources (equipment, people, facilities, etc) are required for each project
- Work alongside the senior team to drive improvements in device testing best practices
- Take the technically lead in ensuring the delivery of medical device development projects
- Deliver high-quality device testing programmes
- Lead technical investigations to identify root causes, and drive resolutions
- Compose and review high quality, detailed documentation for both internal and external use
- Report on and present your team's testing work to clients, who could be big pharma companies, right through to start-ups
What can you offer?
- Degree or equivalent experience in Science, Life Science or Mechanical Engineering
- You will need to be someone who already has a track record of technical leadership, through planning, overseeing, and delivering a medical product testing programme
- Demonstrable experience developing and implementing complex or novel testing methodologies
- Good use of data analysis tools including statistical methods
- Application and understanding of ISO13485, 14971 and 21CFR Part 820
- Working knowledge of test method and equipment verification and validation best practices (e.g., Gauge R&R, IQ/OQ/PQ, FAT, SAT)
- Experience working within a QMS, following principles such as cGxP, ALCOA and data integrity
What other experience could be useful?
Minitab experience, preparing proposals, evaluation of project risks, project planning and costing, understanding of drug delivery, surgical / critical care or diagnostic instrumentation
Now, what's in it for you?
- You'll get to work in high-tech labs / workshops based in a beautiful setting with very good transport links between Cambridge / London
- Joining a team who really value equality, diversity and like to support each other - they have a great social scene, too!
- Genuine opportunities to develop, including access to Udemy Business Learning and Development platform
- 9% non-contributory pension scheme
- Profit share scheme
- 26 days holiday + bank holidays + loyalty days, plus the opportunity to top-up (buy) extra holiday!
- Sabbatical
- Fab insurance protection scheme
- Cycle to work scheme - they even have heated bike sheds!
- Hybrid working, where the job allows