Team Consulting is an employee-owned, award-winning device design and development consultancy. We focus solely on medical devices, supporting international clients from large pharmaceutical companies to start ups. As part of the device testing team, you will be working in our high-tech labs and workshop spaces which are set within our 17th Century barn in the Cambridge countryside, 5 mins from the M11.
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.
As Device Testing Consultant, you will join our team to work on a wide variety of medical devices from drug delivery and diagnostics to MedTech and surgical. You will work with internal project teams to provide testing expertise of medical devices where you will be a key user of Team Consulting’s test labs. You will support the preparation and review of test documents, regularly reporting on and presenting your work to clients.
Why you should join our growing device testing team:
Our specialist device testing team supports testing throughout product development and helps our clients develop new products or deliver self-contained testing programmes. Medical devices can present unique challenges when applying industry guidance and standards. The device testing team works closely with clients to translate these industry expectations into meaningful product requirements and specifications with a whole suite of test methods and protocols tailored to each device.
We work to the highest quality and compliance standards to deliver the complete package needed to support any regulatory submission.
What you will be doing:
- planning and delivering test work for client projects, aligned with Team Consulting’s best practices
- authoring and reviewing technical documents to ensure the highest quality deliverables to our clients supporting projects to work according to Team Consulting’s Quality Management System requirements for testing and data integrity interpreting complex test requirements into a test solution collaborating with project teams to develop test approaches, implement solutions and deliver test programmes to successfully meet project needs identifying the key resources - equipment, people and facilities required for the projects’ needs contributing to technical investigations to identify root causes and drive resolutions
- What we need from you:experience of planning, overseeing and delivering a medical product testing programme
- detailed knowledge of testing methodologies for mechanical functions of drug delivery devices proficiency in the use of data analysis tools including statistical methods
- track record in developing and implementing complex or novel testing methodologies
- some working experience of ISO standards and industry guidance for medical device testing, including Design Verification experience in working within a quality management system, following principles such as cGxP, ALCOA and data integrity clear, concise communication and presentation skills to technical and non-technical audiences, including clients a relevant science or engineering degree or equivalent experience
Desirable but not essential:
- experience of contributing to risk management activities (e.g. FMEA)
- working knowledge of test method and equipment verification and validation best practices (e.g. Gauge R&R, IQ/OQ/PQ, FAT, SAT) experience of using Minitab statistical software
- experience of working in a consulting environment
What we can offer you in return:
- 9% non-contributory pension scheme
- Profit share scheme
- 26 days holiday + bank holidays + loyalty days
- Holiday top-up (buy) scheme
- Great insurance protection bundle
- Sabbatical Bespoke skills development including access to Udemy Business Learning and Development platform
- Cycle to work scheme (+ heated bike shed)
- Social activities throughout the year
- Hybrid working