Test Engineer 2

Intuitive Surgical•Sunnyvale, CA
•Onsite

About The Position

The Test Engineer works with a dedicated product development team in the New Product Verification Department to assure the quality of new designs, identify issues related to designs and processes, and develop harmonized test methods with other Test Engineers. The department supports product and process quality in new product development and production, including the da Vinci and Ion robotic product lines, diagnostic systems, endoscopic instrumentation, and accessories. The role develops and owns verification and validation plans and protocols for design verification and life/reliability testing. It collaborates with Design and Clinical teams to create test methods, performs clinical surgical simulations and automated tests using robotic systems and other equipment, identifies and escalates failure modes, supports failure investigations and root-cause analysis, and documents results. The engineer also designs and documents test fixtures, translates functional requirements into test acceptance criteria, trains test technicians, tracks project completion and constraints, follows company procedures, and ensures adequate test supplies. Work takes place at a desk and in a laboratory. Laboratory work involves animal blood and tissue, detergents, and other chemicals used to reprocess medical devices. Hands-on testing may involve robotic systems, mechanical and electrical test fixtures, microscopes, and other test equipment.

Requirements

  • Bachelor of Science degree in Mechanical Engineering, Biomedical Engineering, or a similar field.
  • At least 2 years of work experience in an engineering organization or research team environment.
  • Familiarity with equipment used for typical performance measurements on electromechanical systems.
  • Experience using tools and measuring equipment such as force gauges, calipers, Instron equipment, and oscilloscopes.
  • Ability to perform basic mechanical engineering calculations to support equipment design, including dimensional analysis.
  • Ability to work with biological samples, including blood, tissue, and organs.
  • Familiarity with Good Documentation Practices (GDP).
  • Proactive and self-motivated, with the ability to learn quickly and understand complex products and processes.
  • Ability to work in a team and independently with minimal supervision.
  • Ability to multitask and manage competing priorities effectively.
  • Integrity and adherence to high ethical, moral, and personal values in decisions, communications, actions, and interactions.

Nice To Haves

  • Experience in the medical device or pharmaceutical industry.
  • Experience with SolidWorks or similar CAD software.
  • Experience with MATLAB, Python, or Arduino.
  • Experience working with electromechanical systems.
  • Basic knowledge of electrical systems, test equipment, and test practices is desirable.

Responsibilities

  • Develop high-level verification and validation test plans for instrument, accessory, endoluminal, or vision projects.
  • Generate and take ownership of test protocols for design verification and life/reliability tests.
  • Collaborate with Design and Clinical teams to develop test methods that sufficiently verify design requirements.
  • Execute test protocols for clinically based surgical simulation and automated testing using da Vinci surgical systems, Ion Systems, and/or other test equipment.
  • Identify and present problems arising during feasibility and design verification testing, and escalate new or persistent failure modes to appropriate engineering teams.
  • Collaborate with engineering teams on failure investigation and root-cause analysis.
  • Clearly document test results and observations in test reports.
  • Design test fixtures and other test aids for design verification and life/reliability testing.
  • Identify processes and test methods that could benefit from new or updated fixture designs.
  • Work with other engineers to develop fixture design concepts and approaches.
  • Document fixtures using SolidWorks and release documents into Agile.
  • Translate functional requirements into appropriate acceptance criteria for test cases and methods.
  • Train test technicians on test methods and procedures.
  • Ensure successful, on-time completion of department projects and communicate constraints to direct management when completion is at risk.
  • Comply with company department and standard operating procedures.
  • Verify and ensure an adequate supply of test articles, equipment, and materials.
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