Senior Engineer, Electrical

3 weeks ago

Fremont, United States THINK Surgical, Inc. Full time $145,000 - $155,000
Job DescriptionJob Description

JOB SUMMARY

As part of the Sustaining Engineering team, the Senior Electrical Engineer is responsible for the design of various electrical and electronic components of surgical robots and their accessories. Component and system design work includes 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. Demonstrates behavior that is consistent with the company’s values and is familiar with Food & Drug Administration (FDA) Quality System Regulations (QSRs).

DUTIES & 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.
  • Performs other duties, as required for project completion.

SUPERVISORY RESPONSIBILITIES

  • N/A

QUALIFICATIONS

Required:

  • 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 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, IEC 60601-1 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.

Preferred:

  • A master’s degree in electrical engineering, or equivalent work experience.
  • Real-time motion and machine control experience.

COMPETENCIES

  • Drives results
  • Optimize work processes
  • Possess a professional and positive outlook
  • High quality work and documentation
  • Manages completion of complex projects on time
  • Collaborative

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 10%).

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.


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