Product Design Engineer (Mechanical)

Location

Thurleigh

Job Type

Permanent

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 is a high growth organisation. 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

This role requires plastic injection molding experience. 

 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 1,600 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. 

Opportunity:

The position is responsible for providing mechanical design, robust development and engineering expertise in the field of NPD (New Product Development), creating and developing designs, innovating using state of the art techniques to produce products which meet identified customer needs. In addition, to carry out mechanical design development, analysis, and tooling development through to validation of final product for FDA submission and CE marking.

Key Areas of Responsibility:

  • Concept Generation: contribute to the concept generation process by producing ideas to solve complex user/engineering issues
  • Design Specifications: contribute to the development of design specifications based on input from product requirements specifications and prototype testing and characterisation
  • Design Development: Maintain ownership of the design through the development process and into production, when required. Will be comfortable and confident working in a broad range of production processes and materials
  • CAD Development: Create, develop ideas and/or maintain designs using 3D CAD software (SolidWorks) in-line with the project key milestones and Quality System requirements
  • FMEA & Risk Analysis: Participate or lead FMEA & RA activities through the full duration of a project, ensuring accurate documentation and successful conclusion of identified actions
  • Tooling Development & Manufacturing transfer: Liaise with and manage tooling and prototype part suppliers in accordance with project milestones and complete acceptability assessments of trial components. Work with the chosen contract-manufacturer and internal colleagues as appropriate to transfer the mechanical product design into volume manufacture
  • Mechanical analysis: Use appropriate methods to perform mechanical analysis of designs to achieve robustness in operation and production in-line with end user needs and the quality plan
  • Planning: be aware of project timelines and contribute to the mechanical sections of the project plan with relevant tasks and estimated timescales
  • 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 in-order to demonstrate that the mechanical design has met specification

Required Experience

About You:

To be successful in this role you must be a highly motivated individual that can demonstrate flexibility and a can-do attitude. You should ensure positive, productive and proactive relationships with a range of internal and external key stakeholders

Essential skills:

  • Degree qualified in a relevant engineering discipline.
  • Experience in designing plastic injection-molded components.
  • Experience with 3D CAD design package, ideally Solidworks.
  • Proven track record of problem solving and innovation.
  • Ability to write clear and concise documentation.
  • Ability to manage external suppliers and technical partners.
  • Ensure records are completed in an accurate and timely manner.
  • Computer literacy and data analysis skills.

Desirable skills:

  • Knowledge and understanding iterative design optimization processes.
  • Experience of developing medical devices.
  • Product design and development experience of complex electro-mechanical systems suitable for high volume production.
  • Familiarity with working under a Quality System.
  • Knowledge of validation and verification testing.
  • Demonstrable experience of production scale up, robustness and validation studies.
  • Familiarity with ISO:13485 and product CE marking.

 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.

 

For further information and to apply for this role, please click APPLY

APPLY

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.