Principal Electronics Design Engineer

Location

Waltham

Job Type

Company Overview

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.

Role & Responsibilities

Opportunity:

The Principal Electronics design engineer is responsible for providing technical solutions and leadership for the electronics engineering team in the design, implementation and verification of our IVD instrumentation platform hardware.

Key Areas of Responsibility:

  • Be aware of project timelines and contribute to the electronics sections of the project plan with relevant tasks and estimated timescales.
  • Create detailed design specifications based on input from product requirements specifications and prototype testing and characterisation.
  • Create robust characterisation and test methods to set tolerances and limits on key technical blocks of the instrument design.
  • Provide innovative and robust design solutions to identified problem / high risk design areas.
  • Review and critique electronic design solutions developed by other team members.
  • Ensure that the key functional technical blocks of the instrument are developed, tested and iterated in a robust and rapid manner.
  • Ensure that the electronic components of the instrument design are integrated into a robust final solution including management of sub-contractor partners where required (PCB fab, board build, component sourcing).
  • Work with the chosen contact manufacture and internal colleagues as appropriate to transfer the electronic product design to manufacturing, inclusive of specifying board stage and any intermediate assembly testing required.
  • Ability to develop and execute the required verification and validation activities needed to demonstrate the electronics design has met specification.
  • Verification/Traceability: Be able to maintain accurate and up to date records of all work carried out in accordance with the quality team/regulatory requirements. Write and execute test protocols and undertake development and verification testing.
  • Use or develop competent knowledge in the required electrical regulations applicable to the development of medical devices.
  • Assist in the release and implementation of change requests and change orders with appropriate documentations. Ensure change is managed effectively through development in accordance with the quality system.
  • Responsible for ensuring the design complies with regulatory standards including EN60601, EN61010, ISO13485 and ISO14971
  • Working knowledge of FMEA, Risk Analysis, RCCA
  • Working knowledge of product CE marking.

Required Experience

Essential skills:

  • Bachelor's degree in Electronics Engineering or similar.
  • Product design and development experience of complex embedded systems.
  • Strong technical knowledge of electronics engineering, both tools and processes.
  • Sound decision making and risk analysis skills on electronics hardware.
  • Experience with schematic and PCB layout design packages.
  • Experience with electronics simulation packages.
  • Experience in analogue, digital, EMC/ESD and RF design.
  • Experience working with C/C++ or any other modern programming language.
  • Knowledge of regulatory standards including EN60601, EN61010, ISO13485 and ISO14971.
  • Excellent oral and written communication skills with the ability to communicate clearly to upper management and other stakeholders.

Desirable skills:

  • Experience in medical device development.
  • Experience measuring and reporting quality-related metrics.
  • Good understanding of Altium 365.
  • Knowledge and understanding iterative design optimization processes.
  • Working knowledge of maintaining design repositories/ database.

 

To apply to the role, please click APPLY

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Thank you for your interest. If you're successful in your application, you may be subject to all or some of the LumiraDx standard pre-employment checks. This includes employment references; Criminal records data checks which are processed as part of our recruitment process 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.