Software Test Engineer

The Fountain Group
Plymouth, United States of America
4 days ago

Role details

Contract type
Temporary contract
Employment type
Full-time (> 32 hours)
Working hours
Regular working hours
Languages
English
Compensation
$ 114K

Job location

Plymouth, United States of America

Tech stack

Testing (Software)
Artificial Intelligence
Unit Testing
C++
Medical Software
Verification and Validation (Software)
System Testing
Software Verification
Information Technology

Job description

The Software Test Engineer will lead software test activities within an R&D environment focused on structural heart technologies and interconnected medical device ecosystems. This role involves software verification and validation for regulated medical devices, supporting compliance with healthcare industry standards and regulatory requirements. The engineer will contribute to software testing across multiple device platforms, ensuring quality, traceability, and adherence to medical software development processes.

Requirements

  • C/C++ programming
  • Software verification and validation
  • IEC 62304 software test methodologies
  • Unit, integration, verification, and system testing
  • FDA 21 CFR Part 820 compliance
  • EU-MDR regulatory compliance
  • ISO 13485 compliance
  • Static and dynamic unit testing tools
  • Medical device software testing
  • Software validation for regulated environments
  • Code repository management

Preferred skills

  • Structural heart or cardiac device domain experience
  • Interventional cardiology knowledge
  • Clinical trial software support experience
  • Experience with first-in-human or pivotal clinical studies
  • Advanced degree in Computer Science, Engineering, Physics, or Data Science

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