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.
Hardware/Software Design and V&V Engineer
Onsite // Hybrid
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)
If you want to hear more about this role, please contact me:
+44 (0) 2038547745