Lead Engineer, Systems

This is a fully remote position, open to applicants in Canada.

📋 Description

• Systems Requirements Definition: Create and document comprehensive product-level and component-level requirements, ensuring they align with clinical needs, user feedback, and the performance of safety-critical systems.

• Risk Management: Perform system-level risk assessments to identify hazards and potential harms, recommending control measures that adhere to medical device regulatory standards (ISO 14971).

• Traceability: Guarantee complete traceability from requirements through design, implementation, testing, and verification to comply with medical device standards (ISO 13485, IEC 62304), confirming that every system requirement undergoes testing and verification.

• Testing and Validation: Partner with the testing team to create system-level test plans, protocols, and verification/validation activities to ensure the product satisfies functional and safety requirements.

• System Integration: Oversee the integration of multi-disciplinary components (software, hardware, mechanical) to assure cohesive functionality and performance in real-time surgical settings.

• Regulatory Compliance: Ensure adherence to all pertinent medical device regulations, including documentation for regulatory submissions. Provide technical assistance for regulatory audits and submissions.

• Cross-functional Collaboration: Collaborate extensively with software, hardware, and mechanical teams to optimize design decisions for the overall system. Engage with product management, clinical engineering, and surgeons to ensure the system aligns with user requirements and delivers value.

• Verification of Design: Spearhead the verification process to ensure that system designs comply with system requirements through thorough testing and simulation. Lead system design reviews to confirm that requirements are fulfilled and safety standards are upheld. Drive the identification of system-level risks and establish robust risk control measures, including overseeing risk control implementation and verifying their effectiveness.

• Validation of Design: Facilitate design reviews to ensure that design outputs conform to approved design inputs and relevant regulatory requirements. Oversee design validation activities, including support for the preparation and maintenance of usability engineering deliverables in accordance with IEC 62366.

• Change Management: Oversee design changes and their impact on system-level requirements, ensuring that changes are properly evaluated for risk and maintain compliance with regulatory standards.

• Documentation: Direct the development 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 in computer/mechanical/electrical/biomedical engineering.

• Over 10 years of experience in medical device development.

• In-depth knowledge of medical device regulatory standards (e.g., ISO 14971, ISO 13485, IEC 62304, IEC 60601, IEC 62366).

• Strong organizational abilities alongside excellent communication and documentation skills.

• Exceptional problem-solving capabilities.

• Familiarity with Good Manufacturing Practices (GMP) and relevant Quality System Standards.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and continuing education.

• Flexible work hours and the possibility of remote work.

• Supportive and innovative work environment.