Software Test Engineer

DivIHN Integration Inc. is seeking a Software Test Engineer for a 6‑month contract in Plymouth, MN, with potential extension to full‑time based on budget and performance.

Key details:
Location
:
Plymouth, MN |
Duration
: 6 months with extension possibility |
Schedule
: 8 AM – 5 PM |
Relocation
:
Accepted, local candidates preferred |
Employment
: W2 only (no C2C or third‑party).

The client is a global healthcare leader with over 115,000 employees worldwide, developing diagnostics, medical devices, and branded generic medicines.

• Provide technical leadership on software test work streams across a product and non‑product ecosystem involving multiple devices.
• Lead and coordinate testing activities, including unit, integration, and system testing per IEC 62304.
• Design, author, and maintain test protocols, cases, and documentation.
• Execute dynamic unit tests and verify software compliance with FDA 21 CFR Part 820, EU‑MDR, and ISO 13485.
• Collaborate with software engineers, architects, Scrum Master, and project managers.
• Document and debug test failures, and drive corrective actions.
• Serve as the primary point of contact for test readiness and test evidence for regulatory submissions.

• Bachelor’s degree in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, or a related field (ABET preferred).
• Minimum 2 years of experience in software testing for medical devices.
• Proficiency in C/C++ (C# exposure helpful).
• Experience with IEC 62304 test methodologies (unit, integration, verification, system).
• Familiarity with FDA 21 CFR Part 820, EU‑MDR, and ISO 13485 validation processes.
• Knowledge of static and dynamic unit test tools and methods.
• Experience with code repositories and maintenance.
• Ability to produce clear, concise design and test documentation.
• Strong analytical, communication, and problem‑solving skills.
• Hands‑on lab testing experience and strong report‑writing skills.
• Fast‑paced Agile environment experience.

• Advanced degree (Master’s or PhD) in Computer Science, Data Science, Physics, or Engineering.
• Experience in first‑in‑human and pivotal clinical trials.
• Knowledge of cardiac anatomy and interventional cardiology.
• Experience with GUI development (Qt preferred).
• Python programming skills.
• Linux familiarity.

• Medical device industry experience preferred.
• Systems:
  Windchill (documentation) and Jira (Agile backlog).
• Traits: proactive, collaborative, strong communicator, problem solver.

C++, C#, GUI application, Windchill documentation system, Jira, Linux OS, Q framework, Agile methodology.

• Read and trace requirements to test cases.
• Verify test case coverage.
• Follow test case instructions during execution.

Two rounds:
Screening and Panel Interview (Onsite preferred).

DivIHN is an equal‑opportunity employer. DivIHN does not discriminate on the basis of race, color, religion, gender, gender expression, age, national origin, disability, marital status, sexual orientation, or military status.