The Lead Engineer, Systems Design, Health, will design and develop requirements, documentation, and aid in the implementation and integration of system features for a medical wearable technology. This role works closely with developers and engineers to develop a platform that will be used in the hospital operating room, clinic, and home setting. The candidate will also work in collaboration with other engineering disciplines, regulatory, quality, product management, program management, and partners to deliver products per the product development roadmap. The candidate will need systems engineering principles in developing, testing, and modifying designs using the agile method.
- Responsible for system-level technical contribution to product development.
- Aid in research and defining system components, modules, internal and external interfaces, engineering analysis, and documentation to satisfy specified requirements for each stage of development from feasibility to production transfer.
- Research and design solutions to complex issues related to electro-mechanical implementation and interfaces based on medical regulatory and standards requirements.
- Proper documentation of system design, requirements, trade matrices, process flows, and user acceptance criteria.
- Support the maintenance and improvement of engineering processes and methods.
- Work directly with internal and external customers/stakeholders for research, requirements gathering, and verification and validation testing.
- Conduct use case definition and convert into concrete engineering system-level requirements and engineering design evaluations.
- Act as the liaison between the R&D team, product management, system testing, and design teams.
- 7+ years in a similar role of project and product development in a regulatory (FDA/EU) landscape for medical devices. Familiar with design for a combined hardware and software system.
- Familiar with most Systems Engineering principles and functional areas: requirements engineering, human factors, integration, testing, and specialty in sensors and electrical engineering.
- Execution of standard medical device regulatory tasks, including requirements traceability, risk assessment, FMEAs, engineering protocols/reports, and verification and validation.
- Experience with multitasking, task prioritization, data analysis, and handling multiple projects of varying complexity.
- Ability to brainstorm, conceptualize and creatively approach design problems, focusing on critical functions while complying with industry standards.
- Strong organizational, documentation, and interpersonal skills as well as a willingness to work within a team-oriented environment.
- Proven experience working under short timelines and delivery dates.
- Computer Skills: Python, C++, MATLAB.
- Experience working with spatial computing, augmented reality, or virtual reality a plus.
- Experience working in wearable and/or mobile computing a plus.
BS in Electrical/Mechanical/Biomedical Engineering or another related field; MS preferred
All your information will be kept confidential according to Equal Employment Opportunities guidelines.