About the role

  • Develop and maintain manual and automated test cases for embedded software
  • Perform functional, regression, performance, stress, and reliability testing
  • Ensure compliance with industry standards and internal quality benchmarks
  • Maintain detailed documentation of test plans, procedures, and results
  • Software requirement analysis, architectural and design specification reviews, and creating use cases
  • Identifying and filling gaps in Use Cases/Test Cases
  • Creating and executing test plans, test designs and test cases and generating test reports
  • Creating and updating trace matrices between requirements and tests
  • Work closely with the software development team to identify improvements and influence requirements for testability
  • Oversee and influence development of test objects to meet needs of protocol
  • Develop and extend protocols and plans as device features evolve
  • Participate in product design reviews and software tool validations
  • Perform peer reviews, software hazard analysis, requirements traceability, code analysis, defect tracking, software metrics, and configuration management
  • Mentor junior QA engineers and contribute to continuous improvement of QA processes
  • Participate in Agile/Scrum ceremonies and contribute to sprint planning and retrospectives
  • Coordinate daily stand-ups and syncs across onshore and offshore teams and establish handoff protocols, test ownership, and defect resolution workflows

Requirements

  • 5+ years of experience in embedded software testing, with a strong mix of manual and automation
  • At least 2+ years in medical device software testing
  • Familiarity with SDLC, test lifecycle, and Agile methodologies
  • Proficiency in Python, Jenkins, and test automation tools
  • Experience working with products from the prototype through 510(k)/ISO clearance and commercialization (preferred)
  • Thorough understanding of software quality assurance principles, practices and metrics
  • Hands on experience using modern software development and quality assurance tools
  • Proven record developing and executing software test protocols for complex medical devices
  • Document test protocols, procedures, and results in accordance with design history file (DHF) and quality system documentation
  • Familiarity with IEC 62304, ISO 14971, FDA 21 CFR Part 820 standards (a plus)
  • Strong analytical and problem-solving skills
  • Excellent communication and documentation abilities
  • Exposure to CI/CD pipelines and source control systems like Git
  • Experience coordinating distributed QA teams, including offshore coordination and remote collaboration tools (Jira, Confluence, Slack, Teams)
  • Leadership/interpersonal skills: Self-Motivated; Results-driven with ‘can-do attitude’; Proactive; Quick Learner
  • Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, Electrical Engineering, or related field

Benefits

  • Competitive compensation and benefits.
  • Opportunities for professional growth and leadership.
  • Work on cutting-edge embedded technologies.
  • Direct impact on patient safety and healthcare innovation.
  • Hybrid work arrangement at Acton office.
  • Travel estimated at 0% (flex depending on business needs).

Job title

Senior Software Test Engineer

Job type

Experience level

Senior

Salary

$94,725 - $142,088 per year

Degree requirement

Bachelor's Degree

Location requirements

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