Software Test Engineer (Contract to hire)

Senseonics, Incorporated; Maple Grove (MN); Hybrid; USD 90,000 - 115,000; Full time

Job summary

Senseonics, Incorporated in Maple Grove, MN is seeking a Software Test Engineer to validate software products and develop test plans, protocols, and automated tests. You will analyze results and collaborate with development engineers to resolve issues.

The role is contract-to-hire with a hybrid work arrangement. Candidates should have a BS in engineering or related field, 5 years in medical device software, and experience with IEC 62304, ISO 13485, and FDA 21 CFR Part 820.

Qualifications

• BS degree in Engineering or equivalent, advanced degree preferred.
• Minimum of 5 years of experience in medical device software.
• Experience in IEC 62304, ISO 13485, and FDA 21 CFR Part 820 standards.
• Experienced in Good Documentation Practices and regulated environments.

Responsibilities

• Review software development and testing activities per IEC 62304.
• Develop Test Plans against Use Cases and requirements.
• Manage testing tasks for embedded software.
• Integrate automated tests into CI/CD pipelines for real-time quality monitoring.

Skills

Software testing

Automation testing

Continuous integration

Education

BS degree in Engineering (or equivalent)

Masters preferred

Job description

The Software Test Engineer validates software products using systematic tests to develop, apply, and maintain quality standards for company products. Develops, modifies, and executes software test plans and test protocols and automated software. Analyzes test results to ensure existing functionality and recommends corrective action. Consults with software development engineers in resolution of problems.

This is a contract-to-hire opportunity, hybrid at our location in Maple Grove, MN.

Duties and Responsibilities include, but are not limited to:

• Review of the software development and testing activities per IEC 62304
• Apply Software Quality Engineering principles throughout the agile product life cycle to identify defects and design flaws
• Review the software requirements to ensure that requirements stated are correct, unambiguous and verifiable
• Develop Test Plans against Use Cases, Requirements and assist in updating and adding new test cases to existing test Protocol.
• Manage Testing tasks for Embedded Software.
• Review test methods and test plans for software projects to determine the software design accuracy according to documented requirements as well as established standards
• Collaborate with the development team to improve the quality of the deliverables and to introduce other quality related improvements in software process
• Prepare & Review test plans & test data and conduct system and integration testing.
• Integrate automated tests into Continuous Integration and Continuous Deployment pipelines for real-time quality monitoring.

Knowledge, Skills, Abilities and Requirements:

• BS degree in Engineering (Electrical, Mechanical, Software or Biomedical), Computer Science, Physics or other relevant technical discipline or equivalent, advanced degree (Masters) preferred
• Minimum of 5 years of experience in medical device software, preferably in embedded, mobile and cloud server applications
• Experienced in Good Documentation Practices
• Experience working in a regulated environment.
• Experience in IEC 62304, ISO 13485, and FDA 21 CFR Part 820 standards within a medical product development environment.