R&D System Engineer

Responsibilities:

• Define the architecture, requirements, and interfaces for the delivery system, ensuring integration and compatibility of subsystems.
• Lead risk management activities, including FMEA, hazard analysis, and safety assessments.
• Maintain requirements traceability throughout the development lifecycle.
• Ensure product compliance with medical device regulations (e.g., FDA, ISO 13485).
• Lead design reviews and ensure subsystem integration.
• Develop test methods and conduct design verification and validation (V&V) activities.
• Remain informed on advancements in cardiovascular technologies and apply industry best practices.

Qualifications:

• Master’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• 10+ years of experience in medical device development, with a focus on transcatheter cardiovascular or implantable devices preferred.
• Knowledge of systems engineering principles and tools, including requirements management, risk analysis, and system integration.
• Experience in V&V testing and process validation, including technical documentation.
• Proficiency in system modeling tools and CAD software.
• Strong analytical, problem-solving, and communication skills.