Senior Test Engineer
On-siteWaltham, Massachusetts, United States
Job Summary
Author comprehensive Software Test Plans and Procedures across the entire Software Development Life Cycle (SDLC). Execute sophisticated testing suites including regression, acceptance, integration, performance, load, and reliability testing across diverse platforms. Maintain strict adherence to ICS and Client SOPs to ensure 100% compliance with Quality Management System (QMS) requirements. Analyze requirements for testability, identifying gaps and providing technical clarity to the development team. Author final reporting processes, including Test Summary Reports (TSR) and detailed defect justifications for regulatory review. Lead risk management activities, including software risk analysis and SFMEA, while enforcing ISO 13485, IEC 62304, IEC 60601, and ISO 14971 standards.
Required Qualifications
- 6+ years of professional Software Testing experience
- 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)
- Experience operating within Agile/Scrum frameworks
- Bachelor's Degree in Computer Science (or a related field) or equivalent professional experience
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