Systems Engineer

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.

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.

We offer a competitive salary, strong benefits and stock options to complete the package.


Key Responsibilities

  • 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.

  • System Analysis

    • 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

  • System Architecture

    • 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


Job Qualifications

  • 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 recruiting@brainscope.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