Senior Test Engineer, Medical Device Software Compliance

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

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