Assist with the verification testing, validation testing, setup of test jigs and writing test reports. Responsible for planning, implementing and monitoring the strategy for medical device manufacturing of new hardware and software releases. Expected to create a document trail that shows the process leads to a consistent result to ensure the highest quality products are produced.
Carry out all verification and validation testing of product software, hardware & firmware as required.
Writing of protocols, verification & validation test plans (this requires gaining an in-depth knowledge of the product to be able to determine what the necessary output is and if it is meeting predefined criteria).
Testing of equipment.
Analysing test results.
Documenting and reporting the analysis of test results.
Review and maintenance of technical documentation.
Providing evidence of both internal and external regulatory compliance.
Troubleshooting in the event of abnormal testing results.
Troubleshooting issues identified by other staff members.
Ensuring accurate records of all verification and validation activities.
Ensure compliance to ISO9001 & 13485 (training is provided if required).
Assist with verification & validation procedures.
Create test cases using Testlink software (training is provided if required).
Reporting of errors or bugs in Mantis bug tracking (training is provided if required).
Ensuring the testing section of the technical files is completed prior to launch (working with the technical team & the RA Department).
Assist in the design, source and commissioning of test equipment and jigs as required.
In addition employees may be required to undertake other duties as reasonably required. In these circumstances training will be given where it is necessary.
Desirable experience with test systems such as Test Link & defect tracking systems such as Mantis.
A keen engineering interest.
Experience in creating plans, protocols, and reports.
Understanding of engineering best practices and test methodologies.
Attention to detail
Good written communication skills
Mathematics - gathering, interpreting and reporting on numbers
Good time management
To be considered for this role, please apply today.