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 Manager, you will line manage our team of technicians, and work with project teams to plan and resource projects (permanent and contract people plus equipment and facilities). You will work across a variety of projects from early-stage development through to formal design verification, ensuring that all test work is performed to the highest standard; also delivering test work for our clients. As an expert in device testing and technical lead, you will also regularly report and present your work and that of your team 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:
- line management and ongoing development of the group of technicians; ensuring continuous development of their skillsets and expertise
- identifying the key resources - equipment, people, and facilities required for the projects’ needs
- working closely with the Head of Device Testing to drive improvements in device testing best practices
- taking the technical lead in medical device development projects, in the field of device testing
- delivering high-quality device testing programmes to plan, across a variety of clients projects
- leading technical investigations to identify root causes, and drive resolutions
- writing and reviewing high quality, detailed technical documentation for both internal use and on behalf of the client
Qualifications and Skills
What we need from you:
- Track record in technical leadership through planning, overseeing, and delivering a medical product testing programme
- Track record in developing and implementing complex or novel testing methodologies
- Proficiency in the use of data analysis tools including statistical methods.
- Application and understanding of key industry standards including 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)
- Proficiency in working within a quality management system, following principles such as cGxP, ALCOA and data integrity
- Degree or equivalent experience in Science, Life Science or Mechanical Engineering
Desirable but not essential:
- Experience of using Minitab statistical software
- Experience supporting sales activities including proposal preparation, evaluation of project risks, project planning and costing
- Detailed understanding of one of the following markets:
- Drug delivery (injectables, inhalation, or drug packaging)
- Surgical / critical care
- Diagnostic instrumentation
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.