Senior Medical Device 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

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