Senior Systems Engineer

Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables. Serve 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), throughout the product lifecycle in accordance with ISO 14971. 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. Analyze and address customer complaints and field issues through risk assessments and technical investigations. 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 of Science required (preferred field of study in: Engineering, Biomedical, Electrical, Mechanical, Systems) 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. Strong analytical and problem-solving abilities. Excellent written and verbal communication skills. Demonstrated ability to collaborate effectively with cross-functional and global teams. Strong organizational skills and attention to detail, particularly for regulatory documentation. Creative out-of-the box thinker who can devise new approaches and processes that meet regulatory needs but adaptive to address business and market needs. Core Competencies Demonstrates expertise in Systems Engineering within the medical device industry, focusing on regulatory compliance, risk management, and system-level design. Proficient in developing and executing test plans, managing requirements, and collaborating with cross-functional teams to ensure product quality and safety. #J-18808-Ljbffr