About the Opportunity
We are currently seeking a Lead System Engineer. This key role will be responsible for performing the systems engineering process, using key engineering principals, providing leadership in systems engineering for related medical product design and development in an FDA 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, 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.
We offer a competitive salary, strong benefits and stock options to complete the package.
Assist in the product planning, project management, design, implementation and testing of medical devices consisting of complex, integrated hardware and software systems intended for the acquisition, processing and analysis of physiologic signals.
Troubleshoot and provide technical assessments of system level performance issues in existing products covering multiple domains (e.g. analog, digital and/or 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
System integration and testing
Define and implement system integration and test protocols (mechanical, electrical & embedded software) including design and development of any necessary test fixtures
Define and implement system 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
Assist in the design and implementation of proof-of-concept simulations and/or prototypes
Develop specifications for device sub-systems and associated data communication, typically including functional specifications, design specifications and verification/validation procedures
Contribute to error budgeting, reliability analysis, design for manufacturability, and design for cost programs
Work within timelines, resources, and budgets for completion of assigned projects
Provide technical leadership on various engineering projects and/or sub-projects
Contribute to specific mechanical, electrical or software designs depending on background and expertise
Bachelor’s and 4-5+ years, required, Master’s and 2+ years’ experience or PhD in Biomedical, Electrical, Computer, or Systems Engineering is preferred
Solid experience with systems engineering processes
Experience with medical devices performing real-time data acquisition is strongly preferred, and experience with EEG systems is beneficial
Basic understanding of the product development life cycle
Beneficial specific expertise includes: Wireless (RF) communication standards, analog circuit design and Bio-Electrical interfaces
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
Experience with Microsoft Office Suite
Working knowledge of one or more of the following is beneficial: Matlab, C/C++, Java, Python, VHDL, VeriLog, and Linux.
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