Systems Engineer, Senior

Job Summary: This position applies cross-functional knowledge of electronics, software, and mechanical technologies to lead the specification, architecture, design, implementation, and test of embedded medical devices.  Will be assigned to substantial assignments, including all levels of architecture, on major projects of moderate to high complexity.  Assignments may be broad in nature and require creativity and ingenuity.    Essential Duties and Responsibilities: Lead cross-functional technical teams in delivering medical devices from initial customer requirements through implementation. Serve as the primary technical point of contact to the customer. Define system architecture and maintain accountability for system design documentation. Lead the evaluation of design alternatives and tradeoff analyses across multiple technologies and engineering disciplines. Lead the definition, analysis, and allocation of requirements derived from customer and user needs. Oversee risk management activities, including design failure modes and effects analysis (DFMEA). Serve as the project’s primary technical authority on applicable medical industry standards. Partner with the test engineering team to define procedures that verify system requirements. Coordinate and manage third-party engagements, including outsourced design activities and testing services. Lead schedule development and budget estimation for new project opportunities. Provide mentorship and technical guidance to less experienced engineers. Lead and support continuous improvement initiatives across engineering processes. Operate under general supervision, with work reviewed for sound technical judgment and overall adequacy. Follow established Forj procedures and engineering practices.   Qualifications: Bachelor’s or Master’s degree in Systems, Software, Electrical, or Mechanical Engineering. 6-9 years experience in developing software and/or electronic-based medical devices. Demonstrated complete understanding and wide application of technical principle, theories, and concepts in the field of medical devices; general knowledge of other engineering disciplines. Proficient at quickly solving medium-complexity system-level problems. In depth knowledge of FDA QSR’s, ISO 13485, and IEC 60601 for medical devices. Experience in interpreting and applying technical regulatory requirements to medical devices. Strong interpersonal, communication (both written and oral) & analytical skills. Excellent interpersonal skills with multiple disciplines & clients. Ability to work independently, but also function as a team player.