Lead Systems Engineer

Job Requirements

Role Summary

Lead systems engineering activities for medical device product development and life cycle management programs, driving system architecture, requirements management, risk management, product integration, verification & validation, and regulatory compliance from concept through commercialization and post-market support.

Key Responsibilities

• Lead system definition, requirements engineering, architecture development, design integration, and verification & validation activities for medical devices.
• Translate user needs, clinical requirements, and business objectives into system requirements and technical specifications.
• Drive compliance with Design Controls, FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, and applicable regulatory standards.
• Lead system-level risk management activities including Hazard Analysis, FMEA, Fault Tree Analysis, and implementation of risk controls.
• Collaborate with cross-functional teams including Software, Hardware, Mechanical, Quality, Regulatory, Manufacturing, and Clinical teams throughout the product lifecycle.
• Support Life Cycle Management (LCM) activities including product enhancements, design changes, component obsolescence, supplier changes, cost reduction initiatives, complaint investigations, CAPA, and post-market support.
• Lead technical reviews, design reviews, problem-solving activities, root cause investigations, and system integration efforts.
• Mentor junior engineers and drive systems engineering best practices across development programs.

Qualifications

• Bachelor's or Master's degree in Systems Engineering, Biomedical, Electrical, Mechanical, Mechatronics, or related engineering discipline.
• 8-12+ years of experience in Systems Engineering with 3-5+ years in Medical Device Product Development and/or Life Cycle Engineering.
• Strong experience in requirements management, system architecture, product integration, risk management, verification & validation, and design controls.
• Hands-on knowledge of FDA, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, and EU MDR requirements.
• Experience with requirements management tools such as DOORS, Jama, Polarion, or equivalent.
• Excellent leadership, stakeholder management, analytical, problem-solving, and communication skills.

Preferred Qualifications

• Experience with connected medical devices, cybersecurity, software-enabled products, and cloud-connected healthcare solutions.
• Knowledge of Agile, Hybrid, and V-Model development methodologies.
• INCOSE Certification (ASEP/CSEP/ESEP) and PMP/CAPM certification are desirable.
• Experience in sustaining engineering, product remediation, manufacturing transfer, and regulatory compliance programs.