Lead Systems (Medical Device) Engineer

Role: Lead Systems Engineer (Medical Devices Experience)

Employment Type: Full-Time (No Visa Sponsorship)
Location: Austin, TX

Job Summary

As a Lead Systems Engineer, you will collaborate with cross-functional teams including Project Management, Regulatory, Quality, Electrical, Mechanical, and Software to translate User Needs into requirements. You will perform Requirement Engineering Analysis (from User need, Design Input, Stakeholder), Systems Hazard Analysis or Risk Analysis, develop Systems V&V Plans, Protocols, and Reports, Systems Traceability and conduct both summative and formative evaluations, as well as design verification testing. You will leverage your expertise in medical device design and development, including design controls, risk management, and compliance with relevant standards and regulations.

Qualifications & Required Experience

• Bachelor’s degree in Systems Engineering (Biomedical, Electrical, or Computer Science).
• 8 years of experience in a medical device company; robotics experience preferred.
• Proficiency in systems analysis utilizing MBSE software.
• Expertise in generating requirements, trace matrices, and design control documentation (21 CFR Part 820, ISO 13485).
• Experience conducting Hazards Analysis, developing FMEAs, and applying risk management processes per ISO 14971.
• Skilled in using Application Lifecycle Management (ALM) and Traceability tools.
• Strong understanding of regulatory and compliance standards (FDA, MDR, IEC 62304, ISO 60601).
• Familiarity with various sensor, actuator, motor, and controller technologies.

Essential Duties & Responsibilities

• Independently design complex systems, including system architecture, design control documentation, test planning, and execution.
• Convert customer and system requirements into detailed subsystem and component-level requirements while ensuring traceability.
• Contribute to and manage segments of product development, ensuring projects progress through design, development, V&V, and launch stages.
• Lead Hazards Analysis and develop project dFMEAs, ensuring alignment with ISO 14971 risk management requirements.
• Plan, execute, and document design verification and validation protocols in accordance with regulatory standards.
• Develop and review design control deliverables, including requirements, design inputs/outputs, risk assessments, and design history files (DHF).
• Demonstrate a strong understanding of customer needs, intended product use, and clinical procedures.
• Ensure compliance with regulatory and quality system standards (FDA QSR, ISO 13485, IEC 60601, IEC 62304).
• Collaborate closely with Project Management, Quality, Manufacturing, Regulatory, Mechanical, Electrical, Software, Clinical, and Marketing teams to ensure project success.
• Identify and support improvements to procedures, policies, processes, systems, and tools to drive quality and compliance.
• Take ownership of assigned work with integrity and accountability.
• Consistently deliver high-quality results with enthusiasm, energy, and a commitment to achieving business objectives.

Job Type: Full-time