Test Engineer

About the Opportunity

We are currently seeking a Test Engineer responsible for performing testing-related tasks for Medical Device and Cloud based Medical Device as Software (MDSW) products.

This position:

  • Reports to Senior Director, Engineering & Manufacturing

  • Is a full time position based in our corporate office, located in Bethesda, Maryland

  • Maintains a customer focus, a commitment to excellence, and adherence to compliance policy and medical device regulation in all work decisions.

  • We offer a competitive salary, strong benefits and stock options to complete the package.

Key Responsibilities

  • Responsible for authoring, reviewing, and software verification and validation test protocols

  • Develop, coordinate, and maintain full software lifecycle (SDLC) validation deliverables for BrainScope software applications, including validation & test plans, acceptance testing, trace matrices, and software validation reports

  • Develop and execute functional test scripts (both manual and automated regression) for custom software applications

  • Execute exploratory/unscripted testing of software

  • Participate in constructive peer review of code changes and test scripts

  • Qualify key processes in support of medical device development, verification, validation, and design transfer

  • Collaborate closely with hardware engineers, software developers and systems engineers in the Bethesda, MD office.

  • Be involved in improvement of test process with respect to FDA regulation

  • Develop/perform integration testing for software and hardware platforms

 Desired Qualifications

  • Bachelor’s and 4+ years, or Master’s and 2+ years’ experience in biomedical, software, or other related engineering discipline.

  • Excellent technical documentation reading and writing skills

  • Experience working with product development in a regulated environment, including medical device standards such as IEC 62304, ISO 13485, ISO 14971 and 21 CFR Part 820

  • Demonstrated understanding of the product development life cycle

  • Experience testing Android applications and/or web applications

  • Familiarity with design controls

  • Basic understanding of how algorithms may be applied in medical devices

  • Hardware testing experience a plus

  • Experience with or familiarity with one or more programming languages (C#, C++, Python, Java, Kotlin) a plus

  • Experience with automated test frameworks a plus

  • Strong written, verbal, and interpersonal skills

  • Flexibility, willingness to learn, and a demonstrated ability to come up to speed quickly on new technologies and technical issues

  • Ability to operate effectively in a multi-disciplinary, team-oriented culture that emphasizes professional development

  • Comfortable working in a fast-paced entrepreneurial culture

  • Strong communication skills


Qualified applicants are encouraged to send their resume and a cover letter including availability to recruiting@brainscope.com. 


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