Senior Lead Systems Engineer

Responsibilities

• Lead design inputs and design outputs for Class II and Class III medical devices, including Requirements Management, Risk Management, Verification & Validation (V&V), and Traceability.
• Own product reliability strategy and execution across the product lifecycle.
• Lead system integration, verification, and validation strategies.
• Develop development plans, protocols, and validation documentation.
• Collaborate across Mechanical, Electrical, Software, Quality, Regulatory, and Project Management teams.
• Drive technical decisions, project execution, and team development.
• Serve in a player-manager capacity, directly leading and developing a five-member systems engineering team while contributing technically to key programs.
• Serve as a technical authority for coagulation programs and system architecture.

Qualifications

• Minimum Knowledge & Experience Required for the Position:
• Bachelor's degree in Electrical, Systems, Biomedical Engineering, or related discipline.
• 15 years of relevant engineering experience; 10 years with advanced degree.
• Experience with FDA-regulated Class II and/or Class III medical devices.