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. 


 

The Office of Federal Contract Compliance Programs (OFCCP) has released a Voluntary Self-Identification Form CC-305. All federal contractors are required to use this form in inviting all applicants and employees to provide information regarding their disability status. Completing this form is voluntary and any answer you give will be kept private and will not be used against you in any way. If you choose to complete the form, please attach it with your job application. The form can be found at https://www.dol.gov/ofccp/regs/compliance/sec503/Self_ID_Forms/VoluntarySelf-ID_CC-305_ENG_JRF_QA_508c.pdf