Senior Technician - Device Testing

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 Senior Technician in Device Testing, 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 providetesting expertise of medical devices where you will be a key user of Team Consultings test labs, whilst also supporting the preparation and review of test documents.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 andstandards. 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:

• testing method development and functional testing at all stages of the development process, from early concept through to verification. This typically includes physical and environmental stress conditioning, detailed inspections, physical dimensional measurements,force and torque testing.
• supporting project teams in planning and delivering test work. This could include some supervision of colleagues or contractors where necessary.
• producing high quality test data and interpreting and presenting findings to the project team and client.
• preparing technical documentation in accordance with project requirements, e.g. test methods, test protocols and reports with reference to all appropriate medical device regulations and standards.
• contributing to technical investigations, including non-conformances.

Qualifications and SkillsWhat we need from you:

• extensive experience in authoring detailed protocols and performing high quality test work
• experience of working in a medical or drug delivery device testing programme
• knowledge of test methodologies for functions of medical or drug delivery devices
• proficiency in the use of data analysis tools and statistical analysis
• track record in developing complex or novel testing methodologies
• structured and methodical problem-solving approach
• detailed understanding of ISO standards and industry guidance for medical devices testing
• working knowledge of quality management systems, including cGxP and ALCOA principles of data management and integrity
• a relevant degree or equivalent experience

Desirable but not essential:

• working knowledge of test method and equipment / verification, validation (e.g. techniques and best practices for Gauge R&R, IQ/OQ/PQ, FAT, SAT)
• experience using Minitab statistical software

• working knowledge of test method and equipment / verification, validation (e.g. techniques and best practices for Gauge R&R, IQ/OQ/PQ, FAT, SAT)
• experience using Minitab statistical software

Additional Role Requirements and Working Patterns

• onsite work required

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.