Lead Hardware 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 1,200 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.
Role & Responsibilities
Due to growth we are looking for a Lead Hardware Test Engineer to join our business on a permanent, full-time basis. This role will be based at our Waltham office and you will be part of our hardware team responsible for end to end delivery of the electronics and mechanical test aspects of the instrumentation hardware. Reporting to the head of hardware you will be responsible for leading the test engineering team in the test solutions for performance verification and validation, product reliability and certification aspects of our IVD instrumentation platform hardware.
- Be aware of project timelines and contribute to the testing aspect of the project plan with relevant tasks and estimated timescales.
- Defining and executing test suites to exercise and characterise system and sub-system functionality and ensure all aspects are fully documented and tested.
- Building testing infrastructure for hardware (opto-electronics and electro-mechanical sub-system) and software rigs.
- Supervising and reporting on the progress of testing.
- Devising process improvements to the efficiency of test activities.
- Working closely with electronics and mechanical design team to debug any design issues.
- Specification & verification of design for test features to allow efficient production testing of new products.
- Interface with manufacturing transfer teams to ensure successful transfer of production solution to our production factories.
- Provide technical training for test procedures and equipment to production and supplier personnel.
- Maintain changes and compliance of the test solution technical data packages including hardware & software design, BoM and related procedures.
- Use or develop competent knowledge in the required regulations applicable to the development of medical devices.
- Experience performing pre-compliance radiated and conducted emissions testing against regulatory requirements.
- Develop and execute test plans and procedures based on requirement specifications and detailed engineering design specifications and maintain traceability matrix.
- Analyse and collate test results and create test reports suitable for further internal analysis and submission for regulatory bodies.
- Bachelor's degree in Electronics Engineering or similar.
- Knowledge of analog and mixed signal components and concepts (ADC, filtering, decoupling, bias voltage/current generation, etc.) and signal integrity on PCB (matching, reflections, etc.).
- Experience building and scaling testing teams.
- Experience with using hardware platforms (e.g. processors/ CPLD) and communication protocols such as SPI, I2C, MIPI CSI.
- Working knowledge of automated test tools and scripting languages such as Python, Perl and C/C++ for lab equipment control and data analysis.
- Requirement verification and validation for electro/opto-mechanical software-controlled systems.
- Experience of electronic fault finding and ability to debug from the circuit diagram.
- Familiar with Quality systems and used to logging/recording all results.
- Familiarity with test equipment such as spectrum analysers, logic analysers, signal generators, power meters, oscilloscope etc.
- Practical experience of building test systems and testing early stage prototypes and final products.
- Familiarity with external test houses for EMC/ ESD testing, environmental chambers etc.
- Knowledge of regulatory standards including EN60601, EN61010, ISO13485 and ISO14971.
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