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Hardware Test Engineer

Employer
LumiraDx
Location
Waltham, MA
Start date
Jun 2, 2022

View more

Discipline
Regulatory, Regulatory Affairs, Research/Documentation
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown

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. LumiraDx currently has over 1,700 employees worldwide.

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

Opportunity

The hardware test engineer will be responsible for test solutions, implementation and performance verification and validation of our IVD instrumentation platform hardware.

Key Areas of Responsibility

Technical

  • Be aware of project timelines and contribute to the electronics and mechanical sections of the project test plan with relevant tasks and estimated timescales.
  • Define robust characterisation of the test methods based on input from product requirements and detailed engineering design specifications.
  • Execute test suites to exercise system and sub-system level functionality and ensure all aspects are fully tested and documented.
  • Build testing infrastructure for hardware (opto-electronics and electro-mechanical sub-system) and software rigs.
  • Develop and execute the required verification and validation activities needed to demonstrate the design has met specification.
  • Confirm system and product capabilities by ensuring all suitable feasibility and testing methods are implemented.
  • Analyse and collate test results and create test report suitable for further internal analysis and submission for regulatory bodies. Maintain traceability matrix.
  • Be the technical authority at project progress and testing review meetings and act as an expert point of contact for colleagues on technical issues related to areas of job responsibility.
  • Work closely with electrical and mechanical design teams to debug design issues.
  • Use complement knowledge in the required regulations applicable to the development of medical devices.
  • Experience performing pre-compliance radiated and conducted emissions testing against regulatory requirements.
  • Experience performing ESD, shielding and other safety testing.

Compliance

  • Working knowledge of medical regulatory standards including EN60601, EN61010, ISO13485 and ISO14971.
  • Working knowledge of product UL and CE markings.

Communication & Collaboration

  • Championing use of the collaborative work tool such as Jira, Jama and other documentation tools.
  • Providing technical excellence.
  • Engage in daily stand-up meeting and effective collaboration with hardware team, sub-contractors and production partners.

Qualifications

Essential Skills and Qualifications

  • Bachelor's Degree in Mechanical and/or Electrical Engineering or equivalent degree is required.
  • 3+ years professional experience in test related engineering role.
  • Demonstrative track record of developing test solutions involving both hardware and software.
  • Practical experience building test systems, testing early-stage prototypes and final products.
  • Solid ability to diagnose, debug and troubleshoot complex embedded systems.
  • Strong technical knowledge of electrical engineering fundamentals and analog / digital / mixed-signal concepts.
  • Knowledge of coding / scripting languages such as C/C++, Python and etc.
  • Familiarity with communication protocols such as PWM, SPI, I2C, MIPI, CSI and signal analysis tools.
  • Hands on experience with lab equipment such as PSU, DMM, oscilloscope, signal analyser, spectrum analyser and solder station.
  • Exceptional analytical problem-solving skills.
  • Strong documentation and organizational skills.
  • Ability to work both independently and in cross-functional collaborative environment.
  • Strong communication skills both written and verbal.

Additional Information

At LumiraDx, diversity and inclusion are part of who we are. LumiraDx is committed to inclusion across race, colour, religion, age, gender, sexual orientation or identity. 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 and external candidates. If you are 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.

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