Device Testing Consultant
Competitive salary - Cambridge (South), Cambridgeshire - Full Time, Permanent
Our client, based in South Cambridgeshire, is looking for a Consultant to join their Device Testing group, to work on a wide variety of medical and drug delivery devices
You will report to the Head of Device Testing and work with project teams to plan and deliver test work for their clients. Working in the laboratories, 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. As an expert in device testing, you will regularly report and present your work to clients. Due to the rural location you will need to have your own transport.
Duties & Responsibilities
- Planning and delivering test work for client projects
- Authoring and reviewing technical documents to ensure the highest quality deliverables to clients
- Supporting projects to work according to our client’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
- Upholding health and safety procedures and guidelines for safe working with hazardous chemicals and pharmaceutical formulations
- To become a knowledge champion for device testing and support change through driving improvements in best practices.
For this role, it is essential that candidates have the following qualifications and skills:
- Experience of planning, overseeing, and delivering a medical product testing programme
- A relevant science or engineering degree or equivalent experience
- 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
- 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
- Structured and methodical problem-solving abilities
- Excellent analytical ability, including data gathering and analysis.
- Clear, concise communication and presentation skills to technical and non-technical audiences, including clients
- Versatility to work diligently and effectively across several projects, both independently and as part of a multidisciplinary team
- Experience of working in a consulting environment.
Please use this form to apply.