JOB SUMMARYSystems 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, and lifecycle requirement management across the product portfolio. This role also leads system-level design verification and validation efforts and supports design transfer to production. The position is based remotely with the expectation of regular travel to the Fremont, CA and Montreal, QC offices.
DUTIES & 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.
SUPERVISORY RESPONSIBILITIESQUALIFICATIONSRequired:- 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.
Preferred:- Align and lead cross-functional teams across the company (Test, Regulatory, Quality, Marketing, Field Service, and Manufacturing).
- Mentor and share knowledge with team members.
- Ability to delegate and obtain appropriate resources to complete projects successfully.
- Can effectively manage outside vendors, contractors, and third party suppliers.
COMPETENCIES- Drives results
- Optimizes work processes
- Balance stakeholders
- Decision Quality
- High quality work and documentation
PHYSICAL DEMANDS & WORK ENVIRONMENT- Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.
- Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.
- Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.
- Occasionally work around moving mechanical parts.
- Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.
- Must be able to travel as business necessitates.
Disclaimer:The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be possible to enable individuals with disabilities to perform the essential functions.
