Principal Software Test Engineer 2 Openings

Plymouth, MA - USA

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

For further inquiries about this opportunity please contact one of our Talent Specialists Hema at or Sri Balan at

Title: Principal Software Test Engineer - 2 Openings
Duration: 6 Months (Temp. to Perm.)
Location: Plymouth MN

Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.

Job Description
The Principal Software Test Engineer leads the design development and execution of the software testing strategy for complex medical device systems. This role is responsible for ensuring that all software whether embedded application level algorithmic or cloud connected and meets the highest standards of safety reliability and regulatory compliance.
The Principal Software Test Engineer functions as a technical authority in software verification guiding cross functional teams in risk-based testing approaches and advanced test automation. This role influences technical direction without direct authority partnering closely with Software Engineering Systems Engineering Quality and Regulatory to ensure robust and compliant product development.

Key Responsibilities
Testing Strategy & Leadership
Lead the development and execution of the overall software testing strategy for medical device products ensuring alignment with system requirements risk controls and regulatory expectations.
Drive risk based verification activities to ensure high risk features and failure modes receive appropriate coverage and depth.
Own and maintain the verification architecture across software hardware and integrated system components.

Test Frameworks & Automation
Architect build and scale advanced test automation frameworks to support continuous integration and continuous validation activities.
Develop automated test solutions for unit integration regression interface and system level testing.
Evaluate and introduce new test tools technologies and methods to increase efficiency coverage and product quality.

Technical Execution
Design and execute verification plans protocols and test cases-including both manual and automated approaches.
Review test plans automation scripts and documentation created by other engineers to ensure consistency completeness and technical accuracy.
Lead root cause investigations defect triage meetings and resolution activities for software and system level issues.

Cross Functional Collaboration
Work across engineering quality regulatory and program teams to ensure verification deliverables are aligned with product goals schedules and compliance needs.
Serve as a technical mentor to test engineers providing coaching on test design automation documentation practices and risk based reasoning.
Communicate verification status risks and readiness with clarity to both technical and non technical stakeholders.

Compliance & Documentation
Ensure all verification activities meet medical device software regulations and standards including (but not limited to):
o FDA 21 CFR Part 820
o IEC 62304
o ISO 14971
o IEC 60601 1 and related standards
Produce and maintain high quality verification documentation that supports design history files audits and regulatory submissions.

Required Qualifications
Bachelors or Masters degree in Software Engineering Computer Science Electrical Engineering Biomedical Engineering or related technical field.
10 years of experience in software testing verification or validation for embedded application level or medical device software.
Expertise in developing test strategies frameworks and automation solutions for complex multi component systems.
Strong programming/scripting skills (e.g. Python C/C Java C# or similar).
Deep understanding of software architecture embedded systems real time operating systems and hardware/software interactions.
Demonstrated experience working within regulated environments (medical device preferred).
Proven ability to mentor engineers and influence cross functional teams without direct authority.

Preferred Qualifications
Experience with CI/CD pipelines and test automation within Jenkins GitLab or equivalent environments.
Hands on experience testing hardware integrated systems firmware sensors or signal processing algorithms.
Familiarity with cybersecurity testing reliability testing or networked medical device systems.
Advanced experience authoring verification protocols traceability matrices and regulatory documentation.

Soft Skills & Leadership Attributes
Strong analytical and problem solving abilities.
Clear communicator capable of breaking down complex technical topics for diverse audiences.
Highly organized documentation driven and detail oriented.
Collaborative mindset with demonstrated ability to lead through influence.
Passionate about safety reliability quality and excellence in medical device engineering.

About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.

For further inquiries about this opportunity please contact one of our Talent Specialists Hema at or Sri Balan at Title: Principal Software Test Engineer - 2 Openings Duration: 6 Months (Temp. to Perm.) Location: Plymouth MN Only W2 candidates are eligible for this position. Third-party or C2...

Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.