Systems Engineer

JOB SUMMARY 

The Systems Engineer will support system-level design, analysis, and integration. This role involves developing system specifications, performing system architecture trade-off analysis, ensuring that all subsystems work together effectively, and failure analysis. Works closely with cross-functional teams to ensure the system meets the needs of robotic surgery, including safety, performance, and compliance with medical device regulation. This position is based in the Fremont, CA office.

DUTIES & RESPONSIBILITIES

• Participate in product development activities through the full product life cycle, including feasibility and prototyping, requirements generation, design and development, and technical review.
• Support manufacturing and field operations with existing products.
• Work with Advanced Manufacturing to coordinate design transfer and release of new products.
• Execute product complaints investigation and closure.
• Initiate and support corrective action per CAPA procedure to prevent product non-conformances.

• Work within quality system environment to produce required technical and regulatory documentation.
• Support design and development projects according to company Design Control procedures and in compliance with ISO 13485. 
• Participate in and/or lead safety risk management activities in compliance with ISO 14971.
• Develop and execute test methods to evaluate proposed design changes.
• Develop and procure test fixtures for design change evaluations and to support manufacturing. 
• Interface with vendors, contractors, and clinicians to develop and realize design requirements.
• Participate in and/or lead system level verification and design validation.
• Contribute to the process improvement and best practice implementation.

• Drive design assurance activities for multiple projects according to established procedures.
• Identify and mitigate technical risk areas through coordination with cross-functional team.
• Understand complex technical topics and issues and communicate such knowledge effectively.
• Interface with other functional departments including Quality Assurance, Regulatory Affairs, and Advanced Manufacturing, to ensure effective collaboration and teamwork.

SUPERVISORY RESPONSIBILITIES

• N/A

QUALIFICATIONS

Required:

• Bachelor’s degree in engineering or science with 4+ years of experience in developing complex systems and/or medical devices.
• Experience in solving complex technical problems using structured approach.
• 2-3 years of experience using Python/Ruby scripts for testing.
• Familiarity with serial debugging.
• Knowledge of GD&T and the principles of Design for Manufacturing (DFM).
• Excellent communication and documentation skills.
• Industry experience in medical device development following FDA design controls, thorough knowledge of FDA Quality System Regulation, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, and IEC 62366 Medical Devices – Application of Usability
• Familiarity or experience with regulatory environments and industry-based standards.
• Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.

Preferred:

• Master’s degree in computer science, mechanical, electrical engineering, or related field.
• Project Management experience.
• Experience in system design involving robotic technology components.
• Electro-mechanical handheld device experience.
• Experience with SolidWorks, Altium, OrCAD or similar tools.
• Familiarity or experience with testing for safety and EMC according to 60601-1.

COMPETENCIES

• Drive results
• Optimize work processes
• High quality work and documentation
• Possess a professional and positive outlook
• Situational adaptability
• Effective communication and collaboration   

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 (up to 25 %).

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.

THINK Surgical, Inc. (“THINK”) is committed to hiring the best qualified candidates for approved positions while engaging in recruitment and selection practices that are in compliance with all applicable employment laws. It is the policy of THINK to provide equal employment opportunity for employment to all applicants and employees, regardless of any protected status. Any qualified applicant or employee with a disability who requires an accommodation in connection with their employment at THINK should contact Human Resources and request an accommodation. THINK also participates in E-Verify, a web-based system that allows THINK to confirm an employee’s eligibility to work in the United States. Actual compensation offered will depend on several factors including but not limited to geographic location, work experience, education, skill level, and/or other business and organizational needs.