Systems Test Engineer
LumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx currently has over 800 employees worldwide.
We have recently launched the innovative LumiraDx Platform, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.
Reporting to the Systems Test Manager and working as part of the Systems Integration Team, the role will be responsible for delivering high quality automated test solutions that support integration of the growing LumiraDx Platform and suite of diagnostic products, including the LumiraDx Point of Care (POC) Instrument and the Cloud-based Connect and Analytics platforms. The role will take ownership of requirements coverage and the delivery of new testing tools and solutions in meeting the needs of the various projects on-going around the organisation.
Key areas of responsibility
* Develop new systems integration tests, and improve on existing test coverage, with a focus on automation, comprehensive coverage and efficient execution.
* Peer review and validation of test cases for other members of the Systems Integration Team.
* Support systems test efforts alongside development and integration as part of an Agile working environment.
* Perform requirements and traceability analysis across multiple systems and interface specifications, and risk assessment outputs, in order to identify new areas for test development.
* Participate in backlog refinement, sprint planning, daily stand-ups, team reviews and retrospectives as part of a SAFe compliant, Agile working environment.
* Work with hardware engineers, software developers and connectivity experts in developing new systems integration solutions.
* Integrate between disparate systems across the portfolio of LumiraDx products.
* Maintain test systems and tools for the Systems Integration Team.
* Report on, and demonstrate, defects found during ad hoc testing and formal verification and validation activities.
* Participate in, and contribute to, daily defect report and triage meetings.
* Participate in the execution and reporting for multiple test suites as part of a regulatory complaint, formal verification and validation campaign, for multiple product types.
* Develop new skills in order to progress and improve the systems test lifecycle and automated test systems and toolsets.
* Create and store verification plans, protocols and results according to LumiraDx processes and in line with specified standards and regulations, for example: IEC 62304, ISO 13485, FDA 21CFR Part 820.
* Ensure compliance with LumiraDx internal QMS and ensure that all outputs are compliant with appropriate international standards and guidelines (as above).
To be successful in this role you must be a highly motivated individual that can demonstrate flexibility and a can-do attitude. You must ensure positive, productive and proactive relationships with a range of internal and external key stakeholders and be self-driven, take ownership and demonstrate high levels of personal accountability.
* Degree qualified in engineering or a closely related discipline OR proven track record of hands-on system level testing.
* Ability to translate product requirements into test requirements.
* Authoring and executing test cases, and performing exploratory testing.
* Able to diligently record evidence and data from test execution.
* Prior experience, or knowledge, of Agile working practices.
* Experience of using requirements, test, software and documentation management tools (such as Jira or Jama).
* Experience of using task tracking tools such as Jira (or equivalent).
* Understanding of a Test Coverage Matrix.
* Practical knowledge of Python and experience in test automation.
* Experience of working in the medical device industry and the application of CE marking directives and applicable device standards.
* Experience in Point of Care and domestic medical device design.
* Practical experience of the product verification and validation lifecycle for a medical device.
* Experience of working to ISO 13485 or FDA 21CFR, part 820 (or equivalent).
* SAFe certified.
* Knowledge of debugging tools and instruments (e.g. oscilloscopes, multi-meters, logic analysers, JTAG, IAR IDE, Ethernet, RS232 and USB interfaces).
* Practical experience of electronics design or test.
If you’re successful, you may be subject to all or some of the LumiraDx standard pre-employment checks. Criminal records data is processed as part of our recruitment and selection processes and, where necessary, in the course of employment, we verify that candidates are suitable for employment or continued employment to comply with legal and regulatory obligations to which the company is subject.
LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security. All staff are responsible for information security and therefore must understand and comply with the Company information security policies, procedures and guidance
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