Senior Validation Engineer

该职位来源于猎聘 Primary Function of Position The Advanced Product Development group within Intuitive Surgical is searching for a Senior Test Engineer to characterize the performance and quality of new mechanical designs of next generation surgical robot systems and robotic components, contributing to the exploration of new applications of surgical robotics. The candidate will work with a team of dedicated individuals within the Advanced Product Development team to assure the quality of new designs, to identify issues related to new designs and processes, and to work with other engineers to develop harmonized test methods. This role is an exciting opportunity to join a small and innovative team in the early phases of product development.

Joining Intuitive

Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient outcomes as our highest priority. The hands-on Senior Test Engineer will work alongside the mechanical design team to evaluate and test robotic systems for minimally invasive surgical applications. The successful candidate will have the technical depth to root cause and recommend solutions to address complex mechanical design issues.

In addition, the candidate shall have the ability to work in an interdisciplinary team to analyze and provide solutions for both lower-level component and higher-level system issues. They must excel in a high-energy, focused, small-team environment, and have a commitment to high quality engineering characterization and failure analysis. They must demonstrate a track record of developing, creating, and innovative engineering solutions.

A strong sense of shared responsibility and shared reward is required as well as a commitment to high product quality.

Roles and Responsibilities

• Develop high level test plans, execute laboratory and validation testing and support engineering validation, trouble shooting, and continuous improvement activities.
• Design and develop test methods and test fixtures (adapters, and mech. Interface) to evaluate the performance and reliability of robotic components and subassemblies.
• Support the development of a supply chain strategy for robotic components that meet target costs and performance requirements.
• Identifies, reports, and negotiates problems that arise during testing, and escalates new or persistent failure modes to appropriate engineering teams
• Support failure investigation and root cause analysis in collaboration with other engineering partners
• Clearly documents test results and observations in test report
• Plan and manage test bench utilization, equipment readiness and test schedules;
• Coordinate internal and external testing resources, including laboratories, suppliers and development teams
• Responsible for documentation of test methods and fixtures utilizing SolidWorks and Product Lifecycle Management systems Skill/Job Requirements:
• Organizational skills and ability to manage deliverables under tight deadlines, set priorities, and manage time effectively.
• Possess a strong mechanical aptitude and a finely honed intuition for electromechanical design
• Strong analytical and problem-solving skills such as FEA, statistical, and experimental design
• Ability to perform mechanical engineering calculations needed to support equipment design or down selection, fixture design, including dimensional analysis.
• Experience using tools and measuring equipment (Force Gauge, Calipers, Instron, Oscilloscopes etc.).
• Exemplary communication and documentation skills with the ability to clearly present to larger groups and distill complex information.
• Highly proficient using CAD to design and document complex test equipment; SolidWorks preferred Required Education and Training
• BS or MS in Mechatronics, Mechanical Engineering, Systems Engineering or related engineering or scientific discipline
• Minimum 5 years working with mechanical engineering products or relevant experience (Robotics experience preferred) Preferred Skills and Experience
• Project management, planning, and changing management skills. Able to manage multiple fast-paced projects simultaneously.
• Experience with FDA QSR 21 CFR Part 820, ISO 13485, IEC 60601, and other related external standards.
• Experience with Good Documentation Practices (GDP)
• Experience working in medical devices or similar regulated industries