System R&D Engineer
About the Opportunity
This key role is responsible for performing the systems engineering process, using key engineering principles, providing leadership in systems engineering for related medical product design and development in an internationally regulated environment. This role will include measuring customer inputs, producing design requirements, performing functional analysis, assessing requirements, selecting appropriate technology and design alternatives, decomposition, synthesis of selected architectures, producing design outputs, verification, validation of product and process solutions with related documentation needed for product realization.
Reports to Senior Director, Manufacturing & Engineering
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 to uphold BrainScope’s “Culture of Quality.”
We offer a competitive salary, strong benefits and stock options to complete the package.
System Architecture and Design
Develop requirements, architectural, and/or detailed design specifications for systems, sub-systems, and associated interfaces.
Contribute to error budgeting, reliability analysis, design for manufacturability, and design for cost programs.
Assist in the design and implementation of proof-of-concept system simulations and/or prototypes.
Provide technical leadership on engineering projects according to background and expertise.
Ensure that products are designed in compliance with FDA, CE, and/or other applicable regulations/standards.
Prepare product build specifications as needed, typically including engineering drawings, schematics, and bills of materials.
System Integration and Testing
Research and integrate new technologies and materials to design and develop complex new test methods and equipment.
Define and implement system integration and test protocols, including selection and/or design and development of test tools as necessary.
Define and implement verification and validation protocols per company guidelines; execute verification and validation tests and associated documentation that comply with US and international medical device regulations and corporate quality management systems procedures.
Plan, develop and execute test protocols to ensure product safety and effectiveness appropriate to the stage of development for the device, encompassing hardware, software and system level components.
Support Software Release processes and documentation, including execution of software verification protocols as part of each release, develop bug-tracking reports and documentation
Troubleshoot and provide technical assessments of issues encountered internally or by customers in existing products covering multiple domains (e.g. electrical, mechanical, software).
Interact with clinical and marketing on the technical assessment and management of device complaints and feedback.
Effectively collaborate with mechanical engineers, software engineers and technicians on a variety of system level issues.
Bachelor’s Degree and 4+ years, Master’s and 3+ years, or PhD in Biomedical, Electrical, Computer, Systems Engineering, or related field.
Experience with systems engineering processes.
Experience with medical device engineering. Specific experience with medical devices performing real-time data acquisition, especially EEG, and/or point-of-care diagnostics equipment is preferred.
Understanding of the product development life cycle.
Understanding of common software development processes in a medical device context.
Demonstrated experience working with and testing electronic products, including software.
Ability to troubleshoot device problems to the circuit board level using schematics, oscilloscopes, multi-meter, and other standard laboratory test and measurement equipment
Beneficial hardware expertise includes wireless (RF) communication standards, analog and digital circuit design and bio-electrical interfaces.
Familiarity with Linux and Android development tools and environments, scripting (Bash, Perl, Python) and/or coding experience a strong positive
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.
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