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Senior Electrical Engineer
1 month ago
As a key member of the Sustaining Engineering team at Think Surgical, Inc., the Senior Electrical Engineer will be responsible for designing various electrical and electronic components of surgical robots and their accessories. This role involves component and system design work, including position sensors, actuators, microprocessors, motion control boards, computers, power supplies, power distribution, creating and releasing technical documentation, performing verification and validation tests, debugging, and releasing to production. The ideal candidate will demonstrate behavior consistent with the company's values and be familiar with Food & Drug Administration (FDA) Quality System Regulations (QSRs).
Key Responsibilities- Perform electrical design of surgical robot components, navigation system, rechargeable battery pack with its charging station.
- Design of printed circuit assemblies and electromechanical assemblies, including prototype development, testing, and troubleshooting.
- Develop electrical test procedures and testing modules.
- Assess design risks to identify hazards and mitigation methods.
- Follow rigorous design control methodology and write concise requirements specifications, architecture specifications, design description, verification plans, and test cases.
- Perform verification and validation, functionality testing, and documentation release.
- Responsible for electrical design documentation development, design transfer to production, and sustaining efforts, including component obsolescence management.
- Develop and execute test methods to evaluate proposed design changes.
- Develop and procure test fixtures for design change evaluations and to support manufacturing.
- Conduct system reliability testing, service support, and provide input for product improvements. Perform initial root cause analysis and debugging related to system errors found during use.
- Track current technologies and translate them into products that will improve effectiveness, safety, manufacturability, and usability.
- Support CAPA investigations per CAPA procedure.
- Support complaint investigations per complaint procedure.
- Effectively work with outside vendors and consultants, as assigned.
- Execute work in accordance with applicable regulatory requirements.
- Understand complex technical topics/issues and communicate such knowledge effectively.
- Interface with other functional departments, including quality assurance, regulatory affairs, and manufacturing, to ensure effective collaboration and teamwork.
- Perform other duties as required for project completion.
- A bachelor's degree in electrical engineering and 6+ years of experience in medical device development as an electrical engineer, or equivalent work experience.
- Knowledge and experience in robotics.
- Experience with schematic capture and PCBA design (Altium Designer preferred). Recent product-focused experience designing multilayered PC boards, including actual hands-on board layout, bring-up, and debug experience.
- Hands-on engineering with proven ability to work well in a team environment.
- Understanding of optical, magnetic, and vision position technologies, principles, and knowledge of commercially available devices.
- Comfortable with all phases of the product development life cycle, including design, implementation, debug, verification, qualification, design transfer, and maintenance.
- Experience in standard bench test equipment, such as oscilloscopes, function generators, logic analyzers, protocol analyzers, etc.
- Proven experience with EMI/EMC/ESD and Safety compliance challenges, design for reliability, and design for manufacturability.
- Experience with serial communication implementations at the protocol layer using transports such as LVDS, IEEE-1394, USB, EtherCAT, and CAN.
- Experience implementing microcontroller, FPGA, and/or CPLD-based designs at the architect level.
- Knowledge of IPC-A-610E, Acceptability of Electronic Assembly.
- Knowledge of ANSI/ESD, Protection of Electrical and Electronic Parts, Assemblies, and Equipment (Excluding electronically initiated explosive devices).
- Excellent communication, documentation, and time management skills.
- Attendance and punctuality are essential functions of the position.
- Knowledge of FDA Quality System Regulation, ISO Quality System requirements, ISO Risk Management requirements, IEC Medical electrical equipment Part 1: General requirements for basic safety and essential performance, IEC 62366 Medical Devices - Application of Usability, and good manufacturing practices (GMP).
- Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
- A master's degree in electrical engineering, or equivalent work experience.
- Real-time motion and machine control experience.
- Drives results.
- Optimize work processes.
- Possess a professional and positive outlook.
- High-quality work and documentation.
- Manages completion of complex projects on time.
- Collaborative.
- Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.
- Physical activities include, but are 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 are 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 10%).
