Hardware/Software Design and V&V Engineer - Medical Devices

Posted 11 April 2023
Salary Competitive
LocationBelgium
Job type Full Time
Discipline Medical Devices
Contact NameBenji Delaney

Job description

Mantell Associates have partnered with a VC backed Medical Device Start-Up, on their search for Hardware/Software V&V Engineer, who will play a pivotal part within the business, helping to bring their products successfully to market! The role offers you the opportunity to an opportunity to play a key role in developing and bringing to market a new Medical Device that improves the quality of life for millions of people.

As one of the early stage and leading team members in a high-tech start-up, you will be able to grow with the team, the company and be part of an exceptional journey with excellent learning and growth opportunities.

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Role:

  • Hardware/Software Design and V&V Engineer

Location:

  • Belgium

Work Style:

  • Onsite // Hybrid

  • ​

Responsibilities:

  • Design and manage the verification and validation tests of the electronic / software components in accordance with design control methodologies (ISO13485 / CFR) in our eQMS system.

  • Responsible for setting up an in-house testing environment and performing the verification/ validation tests of the integrated system during development.

  • Manage the sub-contractors who develop the electronic / software sub-components (both ASIC and PCB electronics).

  • Support the optical system engineer in automating optical test setups.

  • Manage the final electrical verification and validation with external accredited test centers.

  • Design and program test software on tablet/smartphone.

  • Act as the electronics, firmware & software expert to current and future projects.

  • You have experience testing complex hard- and software systems, preferably in a highly regulated industry e.g. medical devices.

  • Experience in electronic design, PCB layout, microcontroller firmware, Python, writing test cases in pseudo code, etc.

  • Experience with common good laboratory / testing / software development practices.

  • Experience with design controls under ISO13485 / 21 CFR 820.30 and understanding of regulatory requirements for designing / testing electronic / software medical devices (IEC60601; ISO 14971; IEC 62366; IEC 62304)

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If you want to hear more about this role, please contact me:

  • benji.delaney@mantellassociates.com

  • +44 (0) 2038547745