[Hiring] Lead Engineer, Systems @THINK Surgical, Inc.

Role Description

Systems Engineering at THINK Surgical, Inc. plays a critical role across multiple phases of the medical device design and development process. The Lead Systems Engineer owns and supports key elements of the medical device total lifecycle, including:

• System definition driven by market and user needs
• Risk assessment activities
• Lifecycle requirement management across the product portfolio
• Leading system-level design verification and validation efforts
• Supporting design transfer to production

This role is based remotely with the expectation of regular travel to the Fremont, CA and Montreal, QC offices.

Qualifications

• Bachelor’s degree in computer science or computer/mechanical/electrical/biomedical engineering
• 10+ years experience in medical device development
• Deep understanding of medical device regulatory standards (e.g., ISO 14971, ISO 13485, IEC 62304, IEC 60601, IEC 62366)
• Good organizational skills and excellent communication and documentation skills
• Excellent problem solving skills
• Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards

Requirements

• Develop and document detailed product-level and component-level requirements
• Conduct system-level risk analysis, identifying hazards and recommending control measures
• Ensure full traceability from requirements through design, implementation, testing, and verification
• Collaborate with the testing team to develop system-level test plans and protocols
• Lead the integration of multi-disciplinary components to ensure cohesive system functionality
• Ensure compliance with all relevant medical device regulations
• Work closely with cross-functional teams to optimize design decisions
• Lead the effort to verify that system designs meet system requirements
• Manage design changes and their impacts on system-level requirements
• Lead the creation of system documentation throughout the development lifecycle

Company Description