Senior Test Engineer

Integrated Computer Solutions, Inc. (ICS); Waltham (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

Integrated Computer Solutions, Inc. (ICS) in Waltham, MA, seeks a Senior Test Engineer to define high-level test strategies and drive verification & validation on complex software projects.

You will author test plans, ensure QMS compliance, and refine requirements for robust, regulatory-ready systems. Ideal candidates have 6+ years in software testing within regulated industries, experience with ISO 13485, IEC 62304, IEC 60601, ISO 14971, and strong Agile/Scrum collaboration skills to deliver

Qualifications

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

Responsibilities

• Author comprehensive Software Test Plans and Procedures across the entire SDLC.
• Execute regression, acceptance, integration, performance, load, and reliability testing across diverse platforms.
• Maintain strict adherence to Quality Management System (QMS) requirements and client SOPs.
• Actively analyze requirements for testability, identifying gaps and providing technical clarity to the development team.
• Prepare Test Summary Reports and detailed defect justifications for regulatory review.

Skills

Software Testing

Regulated industries

Agile / Scrum

Test planning

Risk analysis

Education

Bachelor's Degree in Computer Science or related field

Job description

The Opportunity

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.

Key Responsibilities

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

Qualifications

• Experience: 6+ years of professional Software Testing experience, preferably within a professional services or consulting environment.
• Domain Expertise: Proven experience in regulated industries or medical device software verification.
• Regulatory Knowledge: 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)
• Risk Management: Demonstrated ability to lead risk management activities, including software risk analysis and SFMEA.
• Technical Proficiency: Mastery of diverse testing methodologies (White Box, Black Box, Performance) and experience operating within Agile/Scrum frameworks.
• Education: Bachelor’s Degree in Computer Science (or a related field) or equivalent professional experience.

About ics

ICS blends the art of visual design with agile engineering to help global clients develop "devices that delight." ics’s teams tackle some of the toughest challenges in touchscreen, mobile, embedded, and desktop applications in a wide range of industries. Come join us and help us deliver excellence.