Device Testing Consultant

Job Description

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, youwill 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 TestingConsultant, 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 expertiseof medical devices where you will be a key user of Team Consultings 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 devicescan 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 methodsand protocols tailored to each device.We work to the highest quality and compliance standards to deliver the complete package needed to support any regulatory submissionWhat you will be doing:

• planning and delivering test work for client projects, aligned with Team Consultings best practices
• authoring and reviewing technical documents to ensure the highest quality deliverables to our clients
• supporting projects to work according to Team Consultings 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

Qualifications and Skills

• 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

Equal OpportunitiesTeam 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.