Principal Systems Engineer

Role Overview

• Elicit, document, and manage system-level requirements, ensuring full traceability from user needs to low-level components
• Define system boundaries, interfaces, and data flows between subsystems
• Actively participate in ISO 14971 risk management activities, including Hazard Analysis, DFMEA, and Usability
• Work with V&V team to execute comprehensive Verification and Validation strategies to prove the system meets all design inputs and intended uses
• Act as the technical bridge between Mechanical, Electrical, Software, and Quality teams to resolve design conflicts
• Author and review technical files for global regulatory submissions.
• Provide leadership and direction to technical team, guiding them through the stages of requirements definition, design, implementation, and validation to achieve coherent and efficient system architecture
• Maintain a strong operational knowledge of organization’s technologies, products, customers and customers’ needs
• Perform technical planning, system design and architecture, evaluate alternatives including cost and risk, and supportability of total system
• Manage product documentation through processes.

Requirements

• Bachelor’s degree or higher in engineering from an accredited institution AND minimum of seven (7) years combined industry experience in systems engineering and/or product design in a regulated environment
• High School Diploma/GED and eleven (11) years combined industry experience in systems engineering and/or product design in a regulated environment
• Demonstrated understanding and experience in design, development, and testing of embedded, electro-mechanical medical devices
• Experience in a regulated design environment with medical device development, FDA or ISO registered work experience
• Experience in GMP certified Manufacturing Processes and UL/IEC Standards
• Hands-on experience in System Engineering with working knowledge of C or C++ embedded systems, IoT Communication, and Cybersecurity risk management
• Experience leading system requirements, architecture, integration, and testing through formal design reviews to final verification and validation
• Experience facilitating technical working sessions and engineering reviews
• Proven experience Identifying, quantifying, and mitigating technical risks.

Tech Stack

• Cyber Security
• IoT

Benefits

• Medical, Dental & Vision
• Health Savings Accounts
• Health Care & Dependent Care Flexible Spending Accounts
• Disability Benefits
• Life Insurance
• Voluntary Benefits
• Paid Absences
• Retirement Benefits