Electrical / Firmware / Systems Engineer

Company DescriptionCheckpoint Surgical, headquartered in Cleveland, Ohio, is a privately held medical device company dedicated to advancing peripheral nerve care. Through collaboration with surgeons, the company drives innovation in research, education, and product development. Checkpoint Surgical’s nerve stimulation devices have become a standard of care for intraoperative nerve stimulation, and the company continues to pioneer new solutions that enhance the entire spectrum of nerve care. Learn more at checkpointsurgical.com.Role DescriptionThe primary responsibility of this team member will be to drive the development and launch of innovative surgical devices for peripheral nerves. This will include:Design and development of advanced medical devices for nerve care with focus on Electrical and Firmware Engineering, including development and integration of software, hardware, usability, and interface design.Support new product development via engineering analysis, simulation, preparation and testing of prototypes, and other duties. This will require an understanding of the overall performance of products within the business and helping to identify potential areas of improvement.Design for reliability, regulatory compliance, manufacturability, testability, and cost for current and developed products.Creation of design control documentation including system requirements and functional analysis.Design, Analysis, and Testing of products and prototypes to demonstrate function and required regulatory compliance.Use project management skills to hit deadlines and meet project requirements.EXPECTED AREAS OF COMPETENCEDemonstrated ability to methodically investigate, determine solutions and resolve complex problems using current and new technologies.Ability to develop or identify new technologies to address problems.Working within a quality management system such as ISO 9001 or 13485.Schematic Capture and PCB layout experience preferred.Familiarity with electronics lab procedures including ESD controls and PPE use.Experience designing products to meet safety standards such as IEC 60601, EMC Standards such as IEC 60601-1-2 preferred.Experience with IEC-62304 compliant software development preferredAbility to follow and manage project schedulesAbility to work collaboratively both across internal departments and with our clinical users on the research and development of new products.Professional, concise, tactful and sensitive in communications. Accomplishes objectives when communicating with internal personnel, and external customers and vendors.Demonstrated good written and verbal communication skills including presentation skills.EXPERIENCE AND PROFESSIONAL REQUIREMENTSBachelor’s Degree in Electrical Engineering or related field.5 or more years’ experience with new product development.Project management including planning, execution, budgetary constraints.Understanding of medical device DHF, DMR, and DHR files management and documentation requirements a plus.Desire to work in a fast paced, small company environment as an integral part of a team.