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About the role
- Lead Systems Engineer at THINK Surgical, Inc. overseeing medical device development and compliance with regulatory standards.
Responsibilities
- Systems Requirements Definition: Develop and document detailed product-level and component-level requirements, ensuring alignment with clinical needs, user feedback, and safety critical system performance.
- Risk Management: Conduct system-level risk analysis, identifying hazards and harms, and recommending control measures that meet medical device regulatory standards (ISO 14971).
- Traceability: Ensure full traceability from requirements through design, implementation, testing, and verification to comply with medical device standards (ISO 13485, IEC 62304), ensuring that every system requirement is tested and verified.
- Testing and Validation: Collaborate with the testing team to develop system-level test plans, protocols, and verification/validation activities to ensure the product meets functional and safety requirements.
- System Integration: Lead the integration of multi-disciplinary components (software, hardware, mechanical) to ensure cohesive system functionality and performance in real-time surgical environments.
- Regulatory Compliance: Ensure compliance with all relevant medical device regulations, including documentation for regulatory submissions. Provide technical support for regulatory audits and submissions.
- Cross-functional Collaboration: Work closely with software, hardware, and mechanical teams to ensure design decisions are optimized for the overall system. Collaborate with product management, clinical engineering, and surgeons to ensure the system meets user requirements and delivers value.
- Verification of Design: Lead the effort to verify that system designs meet system requirements through rigorous testing and simulation. Lead system design reviews to ensure requirements are met and safety standards are maintained. Drive system level risk identification and define robust risk control measures, including oversight of risk control implementation and verification of their effectiveness.
- Validation of Design: Lead design reviews to ensure design outputs conform to approved design inputs and applicable regulatory requirements. Own design validation activities, including oversight and support for the preparation and maintenance of usability engineering deliverables in accordance with IEC 62366.
- Change Management: Manage design changes and their impacts on system-level requirements, ensuring that changes are properly analyzed for risk and maintain compliance with regulatory standards.
- Documentation: Lead the creation of system documentation, including requirements specifications, design documents, risk management files, and traceability matrices to ensure complete, clear, and compliant records throughout the development lifecycle.
Requirements
- 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.
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