Senior Systems Engineer

Think Surgical
Full time Full day
Fremont, CA

Company Description




THINK Surgical, Inc. develops, manufactures and markets the only active robotic surgical systems for orthopedic surgery. The systems include two components: a 3D workstation for preoperative planning, and a computer assisted tool utilized for cavity and surface preparation for hip and knee replacement surgeries. The systems have been used in thousands of joint replacements worldwide.


 


 


 




Job Description




The Senior Systems Engineer will take a leadership role in the specification and top-level design control activities for robotic surgery systems used for orthopedic applications. The successful candidate will be capable of solving a broad array of complex problems that bring together multiple engineering disciplines to create original and innovative solutions.  In pursuit of this goal, the Senior Systems Engineer will interface with internal engineering staff, quality assurance, regulatory affairs, product management and external robotics and software consultants.  In addition to these product related activities, the Senior Systems Engineer will be expected to make significant contributions to standard engineering design control and safety risk management procedures as well as working to establish engineering wide best practices.


Travel Requirements: Up to 20%


Job Responsibilities:



  • Applies broad experience and skills in system specification, design, & architecture

  • Operates cross functionally with engineering, marketing, QA, RA, product management, and manufacturing to coordinate product quality through the full product life cycle

  • Works within a quality system environment to produce required technical and regulatory documentation

  • Authors system level requirements that identify various subsystems and requirements for these subsystems.

  •  Manages design control activities and delivers traceable product specifications in compliance with ISO 13485

  • Participates in and/or leads safety risk management activities in compliance with ISO 14971

  • Participates in and/or leads system level verification and design validation

  • Contributes process and best practice improvement




Qualifications





  • Master’s degree in engineering, physics, or a related subject and 5+ years professional experience working with medical devices or other highly regulated field; or a bachelor’s degree and 7+ years professional experience.

  • Experience working on medical device development projects from initial concept through to release to market including product definition, systems architecture, design & development, risk management, and design transfer.

  • Experience with medical device quality standards such as ISO 13485, ISO 14971, IEC 62304, IEC 60601.

  • Experience with requirements management, configuration management, issue tracking tools, etc. 

  • Demonstrated leadership ability and issue ownership including ability to provide guidance and direction to less experienced technical personnel

  • Experience with orthopedic surgical technology and/or robotics technologies a plus

  • Experience authoring quality system processes and work instructions is a plus

  • Excellent written and verbal communication skills required

  • Proven ability to perform complex problem solving and troubleshooting required

  • Strong attention to detail required

  • Must be self-motivated and able to work in a fast-paced environment

  • Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards

  • Attendance and Punctuality are essential functions of the position.


 


                                                              




Additional Information




THINK offers a fast-paced, dynamic environment with the advancement potential of an entrepreneurial company. We provide a competitive compensation package that includes comprehensive benefits, a company-matched 401k plan, and more. We strive to build the strongest and brightest teams in the industry. If you would like to work on tomorrow’s leading orthopedic solutions today, we would love to hear from you.


THINK is an equal opportunity employer that hires a diverse workforce. All qualified applicants will receive consideration for employment without regard to their race, color, national origin, religion, age, sex, disabilities, veteran status, or sexual orientation.


 


 

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