Gentuity, LLC · 2 hours ago
Senior Software Test Engineer
Sudbury, MA
Full-time
Onsite
Senior Level
6+ years expGentuity, LLC is seeking a Senior Software Test Engineer to lead and execute verification and validation (V&V) activities for software components and systems within a Class II medical device. The role involves ensuring compliance with regulatory standards and mentoring junior engineers while developing and executing test strategies and plans.
Health CareManufacturingMedical Device
Responsibilities
Lead the definition and execution of Software Verification and Validation (V&V) strategies for Class II medical devices
Develop and review test plans, protocols, and reports ensuring coverage of software requirements, risk mitigations, and regulatory expectations
Participate in software risk analysis, identifying test requirements based on hazard mitigations and system interfaces
Maintain traceability matrices between requirements, risk controls, and test cases within ALM tools (e.g., Polarion, Jama, Ketryx, Helix ALM, or Jira)
Design and execute manual and automated test cases for embedded, application, and integration-level testing
Perform functional, regression, system, interface, and performance testing across software layers (UI, middleware, embedded, host-PC)
Develop and maintain test automation frameworks or scripts (Python, Robot Framework, C#, or equivalent)
Conduct data integrity, safety, and error-handling testing in alignment with risk controls
Lead test result analysis, defect investigation, and root cause reviews in collaboration with development teams
Verify that software meets intended use, usability, and reliability requirements prior to release
Ensure all testing complies with IEC 62304 (software lifecycle), FDA 21 CFR 820.30 (Design Controls), and ISO 13485 documentation requirements
Generate and maintain test method validation (TMV) documentation where applicable
Ensure Good Documentation Practices (GDP) in all testing artifacts
Support regulatory submissions (e.g., 510(k), MDR) by providing validated test data, traceability matrices, and verification summaries
Participate in internal and external audits by demonstrating compliance with V&V and QMS procedures
Mentor and train junior software test engineers on compliant test methodologies, traceability, and automation tools
Act as a technical lead for one or more software components or subsystems
Provide input to improve test processes, templates, and automation strategies
Collaborate cross-functionally with Development, Systems Engineering, Quality, and Regulatory Affairs to align on testing expectations and deliverables
Qualification
Required
Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related technical field
6–10 years of experience in software verification and validation, with at least 3 years in the medical device industry (Class II or higher)
Demonstrated experience with FDA-regulated and ISO 13485-compliant environments
Hands-on experience with requirements-based testing, risk-based verification, and traceability management
Proven ability to design, execute, and automate test cases for complex embedded and application-level systems
Familiarity with ALM and defect-tracking tools (e.g., Jira, Azure DevOps, Polarion, Ketryx)
Deep knowledge of IEC 62304, ISO 14971, and FDA design control requirements
Experience in testing embedded firmware, GUI applications, or device-host communication interfaces
Working knowledge of test automation (Python, Robot Framework, PyTest, or C# frameworks)
Proficiency with version control (Git), CI/CD pipelines (Jenkins, GitLab CI), and test data analysis
Understanding of cybersecurity, interoperability, and data privacy testing for medical devices
Strong analytical and problem-solving mindset
Excellent documentation and communication skills in a regulated environment
Ability to lead test activities, prioritize tasks, and meet deadlines under quality constraints
Collaborative and adaptable — effective across software, systems, and quality teams
Attention to detail and commitment to continuous process improvement
Preferred
Experience testing catheter-based imaging, diagnostic, or therapeutic medical systems
Experience supporting 510(k) or EU MDR software documentation packages
Familiarity with cybersecurity risk assessment and penetration testing coordination
Knowledge of cloud-connected medical software or AI/ML-based diagnostic algorithms
ISTQB Advanced, ASQ CSQE, or Six Sigma Green Belt certification
Company
Gentuity, LLC
Based in Sudbury, MA., Gentuity is a commercial-stage medical technology firm dedicated to developing next-generation intravascular imaging devices capitalizing on today’s best-in-class technologies.
51-200 employees
H1B Sponsorship
Gentuity, LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2020 (3)
Funding
Current Stage
Growth StageLeadership Team
David W. Kolstad
Chief Executive Officer
Christopher Petersen
Co-founder and Senior Vice President
Recent News
2025-09-09
Medical Product Outsourcing
2025-08-13
Company data provided by crunchbase