Lead Systems Verification Engineer

Company Description

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. 

We 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. 

Job Description

Job Title: Lead Systems Verification Engineer (Waltham, MA)

Job site: 221 Crescent Street, 5th Floor, Waltham, MA 02453

Job Duties:  Act as a hands-on technical expert, guide team in the configuration and functional verification and validation of an integrated software and hardware system, which includes the Instrument, Connectivity, Assay Processing, and Integrated Care Pathways.  

Duties Include:

1. Develop and execute test protocols based on integrated system requirement specifications and high-level subsystem requirements specifications (Black Box System/Subsystem Testing), and maintain traceability matrix.
2. Build testing infrastructure for the integrated system.
3. Collaborate with software, firmware, electronics, and mechanical design team to debug design issues.
4. Develop and design process improvements to promote the efficiency of test activities.
5. Conduct automated tests and develop automation test tools as needed.
6. Ensure full test coverage of the functional requirements of the high quality to support compliance under Quality Management System of LumiraDX.
7. Investigate and resolve bug submission and regression test development.
8. Analyze and collate test results and create test reports suitable for further internal analysis and submission for regulatory bodies.
9. Collaborate with manufacturing support engineers for product performance verification and product process verification for release.
10. Ensure the designs comply with regulatory standards including IEC/EN60601, IEC 62304, IEC/EN61010, ISO13485 and ISO14971.
11. Champion use of collaborative work tools including Jira and Jama.
12. Engage in team meetings and effective collaboration with design team.
13. Drive improvements in software quality.
14. Monitor project timelines and contribute to the testing aspect of the broader project plan.
15. Ensure functional verification activities are carried out properly.
16. Supervise 3 Systems Verification Engineer’s work.

Qualifications

Position requirements: Bachelor’s degree (or foreign equivalent) in Electronics, Electrical/Electronics Engineering, Computer Engineering, Biomedical Engineering, or any related technical field, followed by 5 years of experience in an occupation performing embedded software systems development.

Experience, which may be gained concurrently, must include:

1. 4 years of experience as a technical lead performing embedded software systems development.
2. 4 years of experience in a Systems Verification-related occupation performing manual tests and automated tests.
3. 4 years of experience utilizing test tools and scripting languages, including Python and C/C for lab equipment control.
4. 3 years of experience performing software development in an Agile Scrum environment.
5. 3 years of experience using application lifecycle management (ALM) tools, including JIRA and JAMA.
6. 2 years of experience in Verification and Validation of medical devices.

Additional Information

To apply please refer to Job Code: RS54495

At LumiraDx, diversity and inclusion are part of who we are.  We celebrate uniqueness and believe diversity drives innovation. LumiraDx seeks to deliver high quality, affordable medical diagnostics and healthcare services accessible to everyone around the world, and we wish to reflect a global multi-cultural approach across our business.

Please note, if you wish to submit an application for this role, please consider the following information

This vacancy is open to internal candidates only. As an internal candidate, please notify your line manager before you submit your application. 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.

Please click here to see how we process your data.