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.
· 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.’
· 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
· 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 firstname.lastname@example.org.
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