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.
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.
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
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 email@example.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