Integrated Computer Solutions

Senior Test Engineer

Integrated Computer Solutions • $100K — $130K *
Waltham, MA 02453In-Person
Healthcare
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 6+ years of experience in Software Testing, ideally in a consulting environment.
  • Expertise in regulated industries, specifically medical device software.
  • Strong knowledge of FDA regulations and international standards (ISO 13485, IEC 62304, IEC 60601, ISO 14971).
  • Proven ability to manage risk assessment activities for software projects.
  • Skilled in various testing methodologies such as White Box, Black Box, and Performance testing.
  • Bachelor's Degree in Computer Science or a related field, or equivalent experience.

Responsibilities

  • Develop comprehensive Software Test Plans and Procedures throughout the SDLC.
  • Execute advanced testing frameworks, including regression and performance testing.
  • Ensure strict compliance with ICS and Client SOPs as per Quality Management System.
  • Analyze software requirements for testability and clarify gaps for developers.
  • Create detailed Test Summary Reports and defect justifications for regulatory purposes.

Benefits

  • Opportunities for career advancement in a specialized field.
  • Engagement with cutting-edge technology in regulated industries.
  • Collaborative work environment in a professional setting.
Full Job Description
Senior Test Engineer

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 ICS 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 Integrated Computer Solutions

Integrated Computer Solutions (ICS) is an information technology company that provides software development, consulting, and training services to clients in a variety of industries. The company specializes in open source technologies, including Linux, Android, and Qt, and has expertise in areas such as embedded systems, mobile applications, and user interface design. ICS has worked with clients such as Google, Intel, and Samsung, and has offices in the United States, Europe, and Asia.
Learn more about Integrated Computer Solutions
Size
100 employees
Industry
Information Technology
* Ladders Estimates

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