Medical Device Software Test Engineer

Actalent; Maple Grove (MN); Hybrid; USD 69,000 - 90,000; Full time

Job summary

Actalent seeks a Software Test Engineer to design and execute tests for software used in medical device products, ensuring comprehensive, repeatable, and well-documented testing at software and system levels.

The role supports the creation of detailed test plans, protocols, traceability matrices, and test reports, aligned with product requirements and regulatory standards. Collaboration with engineering and product teams is essential, with a focus on quality and risk management.

Qualifications

• Experience designing and executing black box, white box, and grey box software tests at both the software and system levels.
• Ability to create comprehensive and repeatable test plans, test protocols, traceability matrices, and test reports.
• Knowledge of software verification practices for firmware, embedded software, and implantable Class III medical devices.
• Familiarity with medical device quality management systems and compliance requirements for testing documentation.
• Proficiency using Word and Excel for documentation and reporting.
• Experience with JIRA or other issue tracking software to manage defects and testing activities.
• Experience with PDM or other project data management software for organizing project and test artifacts.
• Hands-on programming experience in C, C++, C#, and Java.
• Ability to review and interpret software and product requirements and translate them into effective test cases.

Responsibilities

• Design and execute black box, white box, and grey box tests for software used in medical device products at both the software and system levels.
• Develop comprehensive and repeatable test plans, test protocols, traceability matrices, and test reports based on software and product requirements.
• Implement and run test cases to verify and validate software functionality, performance, and reliability in support of medical device product development.
• Assist in reviewing software and product requirements to confirm accuracy, clarity, and testability.
• Ensure all testing activities comply with the medical device quality management system, including proper creation, tracking, and storage of testing documentation.
• Participate in software verification efforts for firmware, embedded software, and implantable Class III medical devices.
• Use issue tracking tools such as JIRA (or equivalent) to document, track, and communicate software defects and test results.
• Collaborate with cross-functional teams, including engineering and product development, to support timely resolution of issues identified during testing.
• Contribute to risk management activities related to software testing in accordance with relevant medical device standards.
• Support continuous improvement of test methods, tools, and documentation practices within the software testing process.

Skills

Black box testing

White box testing

Grey box testing

Test plan design

Traceability matrices

JIRA proficiency

PDM software

C/C++/Java programming

Requirements review

Tools

JIRA

PDM

Word

Excel

Job description

Actalent seeks a Software Test Engineer to design and execute tests for software used in medical device products, ensuring comprehensive, repeatable, and well-documented testing at software and system levels.

The role supports the creation of detailed test plans, protocols, traceability matrices, and test reports, aligned with product requirements and regulatory standards. Collaboration with engineering and product teams is essential, with a focus on quality and risk management.