Company Description
We are a leader in liquid biopsy. Every day we transform the lives of cancer patients and their families through the power of liquid biopsy. Our tests unlock essential genomic information from a simple blood test and allow clinicians to make more informed treatment decisions for their patients.
We are dynamic and innovative, focused on the development of new ground-breaking technologies in a fast-paced and international setting. Our exceptional team of talented and driven individuals work together to combine their energy and expertise in world-class research, product development and commercialization to bring new tests to the patients that need them.
If making a difference is in your DNA and you are ready to join the liquid biopsy revolution, then you could be just the person we are looking for to join our team based in Cambridge, UK!
Position
Key Responsibilities:
Collaborate closely with the other teams, especially with Pipeline and Software Development Teams.
Document software testing plans and protocols covering software verification and validation activities.
Translate software requirements /specifications into test protocols.
Execute all levels of testing (System, Integration, and Regression).
Generate verification and validation reports, documenting the outcomes of software testing activities.
Generate and maintain traceability between software requirements and verification / validation.
Research current technology methodologies / trends to support the Inivata systems.
Work with Head of Bioinformatics and IT departments to develop test strategies for Inivata products and on wider company goals.
Support development activities of Inivata software applications.
Design, develop and improve automation scripts and testing environments.
Detect and track software defects and inconsistencies.
Contribute to risk management activities associated with the Software Development process (Hazard Analysis, FMEA, Defect risk analysis).
Provide regular feedback on software test progress, including providing metrics on test development timelines, test execution, quantity and severity of software defects and other relevant information.
HIPAA/GDPR Compliance: Position will
Agree to abide by Employment and Confidentiality Agreements and End User Policies
Commit to stay up to date on training requirements for HIPAA/GDPR
Understand the importance of the proper handling and disposal of ePHI and agrees to follow HIPAA/GDPR Regulations
Abide by the requirements for the proper disposal of equipment containing ePHI
Agree to report breaches and the improper handling of ePHI to the Company’s Privacy and Security Officers
Produce and adhere to proper validation documentation
Requirements
Technical Requirement:
Master’s degree or graduate degree in computer sciences or related field
Prior experience as a software tester or similar role
Skill requirement:
Software development experience in industry (Essential Python experience)
Experience working in a software test role within a regulated environment, ideally within the medical device sector, however aerospace and automotive are also highly desirable fields.
Experience with Unit Testing, Continuous Integration, and System Validation (Essential)
Experience working with a RDBMS (Desired MySQL, PostgreSQL)
Experience working in Linux/Unix system environment (Desired)
Some experience in full stack software development (Desired)
Prior knowledge and experience adhering to Software Development Life Cycle processes (Essential)
Knowledge of defect tracking & test case management tools (Desired Jira, Trac, QC, Bugzilla etc.)
Knowledge of Web-services, Object-Oriented Programming Concepts (Desired)
Practical experience of implementing the requirements of ISO 62304 and FDA guidance on software validation, or equivalent industry standard.
Other information
Our Values guide all our activities:
We are BOLD with the delivery of cutting edge science.
We are PASSIONATE we love what we do, our purpose and our impact on patients is clear
We are CARING we care for our patients, our partners, customers and colleagues
Inivata Limited is based in Cambridge, UK.
No agencies please.
We look forward to reviewing your application!