Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables
Serves as a system technical expert for design changes to subsystems by driving requirement refinement, performing risk reviews, implementing risk mitigations, and developing system verification plans to verify the design change
Perform functional analysis, timeline analysis, and detailed trade-off studies to drive design improvements and cost-reduction to existing subsystems
Troubleshoot system-level issues, perform root cause analysis, and implement effective solutions throughout the development process
Lead risk management activities, including hazard identification and Failure Modes and Effects Analysis (FMEA)
Ensure that all design and development activities comply with regulatory requirements, including FDA Quality System Regulation (QSR) 21 CFR Part 820, ISO 13485, and IEC 60601
Work closely with regulatory affairs and quality assurance teams to prepare and maintain the Design History File (DHF) and other technical documentation for regulatory submissions
Support external audits conducted by regulatory bodies such as the FDA or Notified Bodies
Develop, author, and execute comprehensive test plans, protocols, and reports for system integration, verification, and validation
Provide technical support and expertise to cross-functional teams for post-market surveillance and continuous improvement activities
Manage device and manufacturing process changes, including documentation updates and risk file maintenance
Guide and offer expertise with peers, providing guidance on systems engineering processes and tools.
Requirements
Bachelor degree required (preferred field of study: Biomedical, Electrical, Mechanical, Systems)
M.S. (preferred field of study: Engineering, Engineering Management) considered a plus
4+ years of experience working in the medical device industry/ highly regulated product development industry
6+ years of experience working directly in a Systems Engineering discipline within product development
Proficiency in system-level design, requirements management, and architectural development
Solid understanding of medical device regulations (FDA QSR, ISO 13485) and risk management (ISO 14971)
Experience with requirements management software (e.g., Jama, Polarion, Doors) is required
Experience with systems verification/validation, including test method development