Test Engineer (Contractor)  

About the Opportunity

We are currently seeking a Test Engineer to work on a contractual basis.  This role will be 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, MD.
• Maintains a customer focus, a commitment to excellence, and adherence to compliance policy and medical device regulation in all work decisions to uphold BrainScope’s ‘Culture of Quality.

Key Responsibilities

•  Responsible for authoring, reviewing, and executing hardware and software verification and validation test protocols
•  Qualify key test equipment, hardware testing, and processes in support of medical device development, verification, validation, and design transfer
• 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
•  Collaborate closely with hardware engineers, software development and systems engineers in the Bethesda, MD office.
• Be involved in improvement of test process with respect to FDA regulation

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, IEC 60601, ISO 13485, ISO 14971 and 21 CFR Part 820
• Demonstrated understanding of the product development life cycle
•   Beneficial specific technical expertise includes experience with software testing and hardware testing, familiarity with design controls, and basic understanding of how algorithms may be applied in medical devices
•  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
• Advanced MS Office proficiency
•  Ability to work and communicate with a broad set of team members of varying knowledge base

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

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

Please Apply here.