Medical Device Software Test Jobs (NOW HIRING)

POSITION SUMMARY 

We are looking for a highly skilled Software Verification Engineer to lead digital Test Architecture for several Digital Products supporting Inspire's implantable devices. This role will be in place to help define, update processes, and lead verification strategy for ongoing releases, with a strong focus on quality engineering and software as a medical device (SaMD) testing.

• Engages in detailed technical discussions with other highly talented engineers and explains highly technical concepts to a broad audience including stakeholders
• Coordinates test strategy across different digital products to ensure consistency in approach and QMS artifact content
• Analyzes current process for opportunities to refine, and trains other verification engineers on the implementation of that process

MAIN DUTIES/RESPONSIBILITIES 

• Quality Engineering & Test Strategy

  • Establish the verification strategy for features/releases, including test automation, regression analysis, and levels of software testing (unit, integration and verification).
  • Ensure all quality system, regulatory, legal, and business requirements are met during product development and market delivery .
  • Implement shift-left testing practices, ensuring quality is embedded early in the SDLC.
  • Author Software Verification Test Plans and Reports where needed.
  • Drive and monitor formal testing entrance and exit criteria.
  • Manage issues found during verification activities and help drive them to closure.
  • Guide priorities in tools and processes to achieve globally optimal verification solutions

  Engineering Collaboration & Debugging

  • Collaborate with developers, verification engineers, and product owners to define test strategies, acceptance criteria, and quality goals.
  • Mentor and guide team members performing verification activities in best practices regarding testing including, but not limited to, test case design, test automation and verification strategies.
  • Host regular cross-functional review meetings as part of the software development process.
  • Partner with the development team to provide input on testability to software design
  • Partner closely with the Project Management Office (PMO) and/or Product Management to keep Software Verification activities on schedule and meet quality objectives. This includes giving input to and/or creating project and resource plans and managing expectations accordingly.

   Test Automation

  • Design, develop, and maintain robust automated test frameworks and where manual testing is currently required, design tests with an eye to future automation
  • Build scalable and reusable test automation solutions tailored to the technology stack of the respective product team
  • Integrate automated testing into CI/CD YAML pipelines using the test automation platform built on Azure DevOps.
  • Partner with test automation platform team to establish best practices and norms
  • Provide guidance on advanced automated testing strategies for the organization
• . 

QUALIFICATIONS 

Educational Requirements: 

• Bachelor's Degree in Engineering, Software, Computer Science, or related discipline or equivalent experience 

Required Experience:

• 8+ years of progressive software verification experience 
• 2+ years of hands-on IEC 62304 governed medical device software experience
• 2+ years writing and implementing verification test plans and results reports for regulated software releases
• Strong understanding of software architecture and data flow, and ability to apply that understanding to improve testability and reliability
• Understanding of requirements to test traceability across a large portfolio of test cases
• Able to read, reason about, contribute to production code and provide code review feedback

• Ability to design meaningful, deterministic tests aligned to requirements and risk controls
• Skilled in unit, UI, integration, and endtoend test approaches

• Experience building reliable test automation (e.g., Python (or similar) test scripts, simulators/mocks, and/or API automation)
• Experience integrating test execution into CI/CD

• Ability to produce clear, complete verification evidence suitable for audits (objective evidence, clear steps, expected results)

• Strong communication skills especially in mentoring and coaching across multiple teams
• Experience with agile development methodologies and project management tools (e.g., JIRA, ADO, Agile/Scrum)

Preferred Experience: 

• Advanced level degree in Engineering, Software, Computer Science, or related discipline 

• Class III medical device experience
• Knowledge of healthcare industry standards and regulations (e.g., HIPAA compliance, AAMI TIR 45, IEC 62304)
• Medical device/SaMD background
• Experience building out long-term technical strategy across platforms and establishing incremental achievement milestones
• Familiarity with structured verification workflows and tooling (e.g., test management, traceability systems)
• Experience with C#, React, Python, Dart, Flutter, Azure DevOps, Terraform, or similar technologies 

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