Senior Software Test Engineer (Medical Device)

Provide technical and engineering work for R&D department as directed by the Sr. Manager, Software Engineering. This position will be responsible for developing both manual and automated testing and implementing them in industry standard testing frameworks. The position will be responsible to create test plan/protocol documents (both manual and automated testing) for both full verification and regression testing, execute the test plans, obtain and document the test results including test objective evidence datasheets, perform complete requirements tracing, according to department standards and SOPs.

Responsibilities

Software Test:

• Responsible for evaluating software using automated or manual testing methods and analyzing the results.

• Creating testing procedures to evaluate the performance of the software.

• Building software testing programs that automate testing processes.

• Running the software testing procedures to evaluate the software.

• Documenting all testing procedures according to department standards and SOPs.

• Reporting bugs and making recommendations to improve the software product.

• Retesting software after bugs are fixed to ensure the program works properly.

• Attending meetings with the development team, stakeholders, and other groups.

• Perform software testing against the requirements on the medical device and emulator.

• Perform software unit testing for software test tools.

• Perform code Analysis, Profiling, and Debugging on software tools used for testing of the host application.

Software Requirements:

• Provide input to the software requirements for the host application and software tools.

Software Development:

• Architecting software test automation tools (C++, C#, QT, Selenium or Appium).

• Implement the software test automation tools for the medical device host application and engineering tools (C++, C#, Selenium or Appium).

Software Documentation:

• Responsible for documenting the test protocols, test results, and performing full requirements traceability, according to FDA 510K documentation requirements.

• Responsible for writing software requirements and specification documents for the test tools developed in-house.

System Software Data Measurement:

• Responsible for making observations, taking measurement using laboratory equipment and tools, data processing, statistical analysis and carrying out test protocols.

Software Debugging and Troubleshooting:

• Responsible for testing, system software debugging and troubleshooting the software (Visual Studio, QT, Selenium IDE).

Software Engineering:

• Work with software development in identifying the root cause to the software issues, preparing test cases, plans and procedures.

Leadership:

• Approach to working technical issues that supports a schedule-oriented mindset and work ethic.

Further Tasks:

• Design reviews of the test tools, forms processing for software releases, documentation, other as assigned. This position requires the individual to be on-site. Technical & Functional Skills

Proficient with development tools used with C++/C, and C#: Microsoft Visual Studio

Ability to foster innovation in software testing

Proficient with Windows 10 Operating System

Proficient with using Atlassian Jira and BitBucket

Proficient with developing software test protocol documentation and test results capture for medical device are required. Need to demonstrate these skillsets through previous experiences

Proficient with writing advanced C++ and C# code for complex system, managed code, Microsoft .NET framework environment, SQL database, Windows based GUI application development

Proficient with developing automation testing tools using Selenium or Appium or equivalent tools – Demonstration of the previous experience in this domain is required.

Profiling/Optimizing software

Agile Software Development Methodology and Processes (Jira)

Experience with testing software hosted on medical device. Medical devices standards like IEC62304, ISO14971, IEC60601

Experience designing and running unit tests Minimum Requirements

Bachelor of Science in Computer Science, Physics, Math, Electrical Engineering.

5+ years of experience in software development

6+ years of software testing and automation for medical device

Ability to course correct as needed due to changing priorities Preferred Qualifications

Knowledge on B-Mode Ultrasound is plus

Design experience with real-time systems, state machines and standard Windows applications

Knowledge of FDA cybersecurity requirements, NIST, GDPR, EU ENISA

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)