Senior Software Quality Engineer

Medical Devices Company
San Jose, CA

Roles & Responsibilities

Responsibilities:
• Determines scope of work for complex tasks and establishes project test schedules. Responsible for ensuring team adheres to project test schedules.
• Responsible for establishing and documenting software project test strategies and techniques in a Test Plan. Responsible for translating requirements for complex software systems into traceable test suite documentation including: Test Designs, Test Procedures, Automated Test Scripts or code.
• Responsible for executing Test Procedures, automated test scripts and code, exploratory testing both on the instrument and in a simulated environment, submitting clear and concise defect reports, regressing defect corrections, and entering requests for change to improve the usability of the product.
• Participates in code inspections, technical reviews, and design reviews.
• Work with application developers to assess the application’s potential cyber security risks and develop test plans accordingly.
• Works proactively with staff from Systems Verification and Validation to determine the best strategy for project test coverage.
• Presents project test data at project review meetings, and presents product acceptance determination. Communicates project test status, progress, problems and changes to program as well as functional management. Recommends options to resolve testing issues. Participates in defect reviews.
• Initiates interaction with other departments to maintain open information channels and to facilitate transfer of technology. Demonstrates knowledge of Manufacturing, Service, Quality/Regulatory, Training requirements and actively participates in multifunctional product development teams and develops expertise recognized by other technical groups in BDB.
• Develops knowledge of BDB products through training and use. Contributes to the advancement of process capability for software quality engineering. Leads brainstorming sessions for software quality engineering process improvements, identifies specific improvement options, and presents to management. Writes/revises Desk Procedures, with appropriate reviews and approvals. Recommends innovations and improved methods, and tools. Recommends and participates in functional training to advance the capabilities of the group.
• Continues pursuit of software quality engineering knowledge through seminars, webinars, technical publications, and contact with members of profession at technical meetings.
• Provides technical guidance and instruction to less senior technical staff.
• Performs other related duties and assignments as required.
• Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements. Participates as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the attention of management.
• Promotes a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices.

Experience Required

• Must possess ability to communicate technical ideas clearly.
• Demonstration of value creation for the business through effective implementation of software testing methodologies, process improvements, productivity improvements, and applied software testing practices.
• Good understanding of how to test software applications for cyber security risks.
• Effective team leadership competence.
• Ability to function in a team setting.
• Ability to motivate, lead, coach.
• Effective project planning and organizational skills.
• Demonstrated ability to perform detail-oriented work with a high degree of accuracy.
• Effective oral and written communication skills.
• Effective analytical, quantitative, and problem solving skills.
• Effective interpersonal skills.
• Effective goal settings skills.

Skills & Certifications

Preferred
• Experience with the Agile\\Scrum process.
• Experience working on software for Flow Cytometers or other related medical devices.

Provide independent verification of software products that have been developed according to pre-approved software design requirements and specifications. Independently develops, maintains and executes test cases both manual and automated. Discovers, documents and tracks software defects in a bug database. Plans and implements the setup of test environments to perform functional testing of integrated software and hardware in a lab setting. Facilitates the core project team to ensure all facets of software product testing is accomplished within project timelines. Develops, publishes, and implements test plans. Requires a bachelor\'s degree in Computer Science or related field and at least 5 years of industry experience coding in C++ and/or C#. Writes and maintains test automation. Develops quality assurance standards. Knowledge of software quality engineering and testing methods at all levels (unit, integration, system, V&V, acceptance) applied within the software development lifecycle. Experience using Visual Studio/TFS, Test Manager, CodedUI. Ability to apply and use software quality tools for test case management, test automation, and defect tracking management. Familiar with MS Windows 2003, 2008 Server, NT, UNIX and/or Solaris environments. Knowledge of database backend testing, hands-on developing complex SQL queries, UI, functional testing, Work Flow, and use case testing. Certified Software Quality Engineering � ASQ certification is a plus. Relies on experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. Works under general supervision; typically reports to a manager. A certain degree of creativity and latitude is required.

Eligibilities & qualifications

Qualifications:
Required
• Typically requires a BS degree in a related discipline (PhD is equivalent to MS plus two years of directly related technical experience; MS is equivalent to BS plus one year of directly related technical experience) and six years of direct technical experience in software quality engineering, or equivalent combination of related education and experience.

Posted 2026-06-09

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