System Engineer

Overview

We are seeking a Systems Engineer with experience in medical device product development to support system architecture, requirements development, risk management, and verification & validation activities throughout the product lifecycle.

• Develop and manage system, product, and subsystem requirements with clear rationale and traceability.
• Perform system analysis, risk assessments, and FMEA activities.
• Decompose and apply medical device standards (ISO 14971, IEC 60601 series, ISO 80601 standards) into product requirements.
• Define system-level requirements for software, electrical, and mechanical subsystems.
• Develop and maintain traceability matrices, risk management documentation, and Design History File (DHF) deliverables.
• Create V&V protocols, test plans, and support verification and validation activities.
• Collaborate with cross-functional teams including R&D, Quality, Regulatory, and Manufacturing.
• Lead technical reviews and support continuous process improvements.

• Bachelor's or Master's degree in Electrical, Electronics, Mechanical, Computer Engineering, or a related field.
• 5+ years of experience (Bachelor's) or 3+ years (Master's) in Systems Engineering, System Design, System Architecture, or Hardware Engineering.
• Experience with New Product Development (NPD) and full product lifecycle activities.
• Strong knowledge of ISO 14971 and IEC 60601 medical device standards.
• Experience with risk management, requirements development, system integration, and V&V.

• Experience developing electromechanical medical devices with hardware and software components.
• CSEP (Certified Systems Engineering Professional) certification is a plus.
• Familiarity with systems architecture, continuous improvement, and product lifecycle management.