About the Opportunity

We are currently seeking a 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, Manufacturing & Engineering
  • Position is 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 contractor rate. A competitive salary, strong benefits and stock options are offered to full time employees.

Key Responsibilities

• • Assist in the 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.

Desired Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• • Bachelor’s and 4-5+ years, Master’s and 3-4+ years’ experience or PhD in Biomedical, Electrical, Computer, or Systems Engineering is required.
  • Experience with systems engineering processes.
  • Experience with medical devices performing real-time data acquisition. Experience with EEG systems is strongly preferred.
  • Basic understanding of the product development life cycle.
  • Beneficial specific expertise includes: Wireless (RF) communication standards, analog circuit design and Bio-Electrical interfaces.
  • Beneficial software experience includes: Matlab, C/C++, VHDL, VeriLog, and Linux.
  • 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.

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

Please see job details here.