Senior Systems Engineer

Role Overview

• 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

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs