Team Consulting Ltd.

Team is looking for a Senior Device Testing Consultant to join our Device Testing group, working on a wide variety of medical and drug delivery devices. You will report to our Head of Device Testing and work within internal project teams to provide testing expertise. You will be a key technical expert and leader within the group. This role requires extensive previous experience working in laboratories as the expectation is that you will plan and manage test activities as well as lead and supervise junior team members and associates. This role also includes significant client interaction, proposal generation and representing Team at external events. Assist with Team's project activities by planning, leading, and delivering testing milestones. Work across a variety of projects from early-stage research & development through to formal design verification and post-market investigations. Lead by example by following Team's health and safety procedures and guidelines when handling hazardous chemicals, pharmaceutical formulations or carrying out other activities related to the DT consultant role. Advise and facilitate use of novel technologies and laboratory equipment to enable device testing method development & validation and equipment & software validation across a variety of technical areas. Collaborate on, prepare, review, and follow key documents in accordance with project requirements and Team's quality management system e.g. SOPs, WIs. Advise, review, and prepare testing-related e.g. test plans and quality-related documentation e.g. lab equipment/test script validation plans, reports, non-conformity investigation reports. Team Leader, Engagement Manager, Technical Lead and/or Project Manager for device testing programs. Supervise or arrange for appropriate supervision of Test Technicians. Determine appropriate test data verification approach. Advise on appropriate statistical analysis approach and interpretation of complex data. Train users on test methods, equipment, and provide expert advice on testing approach, test processes, standards, and sampling strategies. Proposal writing and client liaison to determine appropriate test strategy, costing and timelines. Represent Device Testing at Technical Symposiums/Conferences and create marketing content as required. Source, help select, and liaise with 3rd party suppliers. Internal and external presentation of test-related subjects to project teams, clients, company, and wider scientific community. Qualifications and skills 3+ years of experience working on a variety of projects within a medical product, cGxP, ISO 13485 or other regulated industry laboratory environment. Extensive experience of adhering to Health and Safety practices and policies and safely handling hazardous substances, with Health and Safety knowledge related to area(s) of expertise. Extensive working experience of ISO standards and industry guidance for testing of medical products. Extensive working knowledge of cGxP and ALCOA+. Able to identify and critique laboratory equipment used within area(s) of expertise. Extensive experience of developing and validating complex or novel test methods and/or ISO standard test methods and validating laboratory equipment and associated software (IQ/OQ/PQ). Experience of training colleagues within multiple areas of technical expertise. Previous experience of creating or reviewing technical documents e.g. test plans, methods, protocols, reports, training documentation, validation documents, non-conformity investigation reports. Able to explain rounding rules and how to choose the appropriate statistical analysis tool required. Expertise in using Minitab statistical software or equivalent. Extensive experience of working to ISO 13485 requirements. Previous experience of authoring risk assessments, COSHH assessments or other relevant Health and Safety documentation. Extensive experience of design verification testing. Previous experience of liaising with laboratory equipment. manufacturers on validation requirements. Experience of writing about technical topics to non-technical audiences. Extensive experience using Minitab statistical software. Extensive experience of working with 3rd party suppliers. Leadership/ Consultancy Skills Extensive experience of working in a medical device consulting environment or equivalent Proven excellent communication skills, both written and verbal, on a range of technical subjects to technical, non-technical audiences and clients. Versatility to work diligently and effectively across a range of products, both independently and as part of multi-disciplinary teams. Experience of presenting complex laboratory findings and conclusions to technical and non-technical audiences. Adept at networking and able to build a profile within Team. Demonstrable ability to plan and organise test activities or design verification test programmes. Structured and methodical problem-solving abilities and able to share this knowledge effectively. Excellent time management, with ability to adapt to changing priorities, projects, and tasks. Able to define timelines, prioritise tasks and communicate this effectively. Experience of writing proposals or equivalent. Experience of leading effective teams. Experience of external networking. Able to critically review, challenge the status quo if necessary and provide alternative solutions and explain their chance of success. Personal Qualities Passionate about working in the medical device field. Conscientious and motivated, with an eagerness to continuously learn and improve. Aware of own limitations and those of others, knows when to ask for or offer help. Practical and hands-on whilst using good common sense. Methodical approach to tasks, with an eye for detail. Always shows integrity and honesty. Dependable, flexible, and calm under pressure. Approachable, with the ability to lead and work collaboratively as part of a team. Enthusiastic with a positive outlook and solutions focus. Respectful of others' opinions and contributions and is supportive of colleagues. Actively shares own knowledge and experience. Has the determination and dynamism to drive complex issues through to successful conclusion. Proactive, actively seeks out others and brings colleagues together collaboratively. Additional role requirements and working patterns Full time, on-site, laboratory-based role with opportunities to work from home. 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.