Organise the planning, implementing and monitoring the verification and validation strategy for medical device manufacturing of new and existing hardware and software releases.
Expected to measure and analyse the process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result to ensure the highest quality products are produced.

Main Responsibilities:

Oversee all testing of product software, firmware and hardware as part of research and development, including:
Pilot testing
Design phase/module testing
Verification testing
Validation testing
Main responsibilities of testing include:
Documentation of process, test plans and protocol development
Creation and set-up of test jigs and test environment
Completing testing and data collection
Analysis and reporting on test outcomes
Troubleshooting in the event of abnormal testing results
Troubleshooting issues identified by other staff members
Create and maintain test cases using Testlink software (training is provided if required)
Reporting of errors or bugs in Mantis bug tracking (training is provided if required)
Working alongside the RA and Technical teams to ensure the Testing Section of the Technical File is completed as per the procedure, to ensure compliance to ISO 13485 prior to launch of new and existing products.
Assist in the design, sourcing and commissioning of test equipment and jigs, as required.
Qualification/Experience:

Experience of working within a regulated environment is necessary i.e. aerospace, automotive, military, etc. but desirable if experience working within pharma and medical device design and development
3+ years of experience in product testing
Any relevant qualifications in engineering subjects
Experience of implementing engineering best practices and test methodologies
Experience creating verification and validation test plans, protocols, and reports
Experience with requirements management, risk based testing approaches, defect tracking, and configuration control tools
Desirable experience with product development verification per FDA design control and ISO 13485

Skills Required:
• Attention to detail – it is vital to pay attention to every test result and measurement and notice when something isn’t quite right
• Analytical thinking – as well as identifying when there is an issue, part of the role can be to suggest why there might be an issue, as well as potential fixes
• Team working – these professionals can be working with people throughout the manufacturing process
• Good written communication skills – report and protocol writing is an essential part of the job
• Organisation skills – protocols and timelines have to be strictly followed
• Mathematics – gathering, interpreting and reporting on numbers is a significant part of the role
• Computer skills – there is a lot of organisation and interpretation of data required, computer skills are essential
• Time management – there is a timeline of testing that needs to be followed
• Initiative – test engineers need to be able to think on their feet and come up with new and inventive ways to challenge the processes and fix problems

Department: Technical

Reports to Senior Technical Manager and Technical Project Manager

Salary, based on experience from £23,000 - £27,000 per annum