Senior Test Engineer

Integrated Computer Solutions • Waltham, MA

1d • Onsite

About The Position

ICS is seeking a Senior Test Engineer in our Waltham, MA office to work with complex software development projects to define high-level test strategies. In this role, you'll be driving the verification and validation (V&V) plans, implementing quality analysis and refining requirements to ensure mission-critical systems are robust, clear, and compliant. Much of the equipment we test is located in our Waltham office.

Requirements

• 6+ years of professional Software Testing experience, preferably within a professional services or consulting environment.
• Proven experience in regulated industries or medical device software verification.
• Deep working knowledge of FDA and international standards, specifically: ISO 13485 (QMS), IEC 62304 (Software Life Cycle), IEC 60601 (Medical Electrical Equipment), ISO 14971 (Risk Management).
• Demonstrated ability to lead risk management activities, including software risk analysis and SFMEA.
• Mastery of diverse testing methodologies (White Box, Black Box, Performance) and experience operating within Agile/Scrum frameworks.
• Bachelor’s Degree in Computer Science (or a related field) or equivalent professional experience.

Responsibilities

• Author comprehensive Software Test Plans and Procedures across the entire Software Development Life Cycle (SDLC).
• Execution of sophisticated testing suites, including regression, acceptance, integration, performance, load, and reliability testing across diverse platforms.
• Maintain and enforce strict adherence to ICS and Client SOPs, ensuring 100% compliance with Quality Management System (QMS) requirements.
• Actively analyze requirements for testability, identifying gaps and providing technical clarity to the development team.
• Author the final reporting process, including Test Summary Reports (TSR) and detailed defect justifications for regulatory review.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior