Software Verification Engineer

Katalyst Healthcares & Life Sciences; Newton (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

Katalyst Healthcares & Life Sciences is seeking a meticulous Medical Device Software Verification Tester to verify software used in our medical devices and ensure compliance with regulatory standards and internal quality requirements.

This role involves designing, implementing, and executing test plans and procedures to identify software defects, performing manual and automated testing, documenting results, and collaborating with software developers and systems engineers to uphold FDA, ISO

Qualifications

• Bachelor's degree in computer science, software engineering, biomedical engineering, or related field.
• Minimum 5+ years of software testing experience, preferably in medical devices.
• Experience with testing tools and frameworks such as ClearQuest and Jama.
• Familiarity with FDA 21 CFR Part 820, ISO 13485, IEC 62304.
• Strong understanding of software development and testing methodologies.
• Excellent analytical and problem-solving skills.
• Attention to detail and high accuracy.
• Proficiency in scripting or programming languages (Python, Java) for test automation.
• Good communication and teamwork skills.

Responsibilities

• Test planning and design based on software requirements and design specs.
• Develop test plans, test cases, and test scripts.
• Ensure coverage of functional and non-functional requirements (performance, reliability, security).
• Execute manual and automated tests to identify defects.
• Conduct regression testing and exploratory testing.
• Document results, defects, and steps to reproduce.
• Generate test reports and defect logs for regulatory compliance.
• Collaborate with developers and systems engineers to understand requirements and functionality.
• Ensure testing activities comply with FDA, ISO 13485, IEC 62304.

Skills

Test planning

Test design

Regression testing

Exploratory testing

Manual testing

Automation

Python

Java

Documentation

Communication

Regulatory compliance

Education

Bachelor's degree in Computer Science or related field

Tools

ClearQuest

Jama

Job description

We are seeking a meticulous and detail-oriented Medical Device Software Verification Tester to join our team. The successful candidate will be responsible for verifying software used in our medical devices and ensuring compliance with regulatory standards and internal quality requirements. This role involves designing, implementing, and executing test plans and procedures to identify and document software defects.

Responsibilities:

• Test Planning and Design.


• Develop comprehensive test plans, test cases, and test scripts based on software requirements and design specifications.


• Ensure test plans cover all functional and non-functional requirements, including performance, reliability, and security.


• Test Execution:


• Execute manual and automated tests to identify software application defects.


• Conduct regression testing to ensure existing functionalities remain unaffected by new changes.


• Perform exploratory testing to uncover potential issues not identified by formal test cases.


• Documentation and Reporting:


• Document test results, including detailed descriptions of defects and steps to reproduce them.


• Generate and maintain test reports, defect logs, and other documentation required for regulatory compliance.


• Communicate test outcomes and defect status to development teams and management.


• Collaboration:


• Work closely with software developers, and systems engineers, to understand software requirements and functionality.


• Compliance and Standards.


• Ensure testing activities comply with relevant regulatory standards (e.g., FDA, ISO 13485, IEC 62304).


• Stay updated with industry best practices and evolving regulatory requirements for medical device software.

Requirements:

• Bachelor's degree in computer science, Software Engineering, Biomedical Engineering, or a related field.


• Minimum of 5+ years of experience in software testing, preferably in the medical device industry.


• Experience with testing tools and frameworks (e.g., ClearQuest, Jama).


• Familiarity with regulatory standards and guidelines for medical devices (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).


• Strong understanding of software development and testing methodologies.


• Excellent analytical and problem-solving skills.


• Attention to detail and a high level of accuracy.


• Proficiency in scripting or programming languages (e.g., Python, Java) for test automation.


• Good communication and teamwork skills.