Senior Hardware Test Engineer

About the role

The New Product Verification Department at Intuitive is dedicated to ensuring that our products meet the highest standards of safety, reliability, and effectiveness. Our team works closely with product development teams to verify new designs, identify issues, and develop harmonized test methods. The Senior Test Engineer plays a crucial role in this process, contributing to the quality and success of our robotic-assisted surgery and minimally invasive care solutions.

Responsibilities

• Develops high-level test plans for instrument, accessories, endoluminal, and vision projects
• Generates and takes ownership of test protocols for Design Verification and Life/Reliability tests
• Ensures design requirements are sufficiently verified by collaborating with appropriate cross-functional partners
• Executes test protocols for clinically-based surgical simulation and automated testing using da Vinci surgical system, Ion Systems, and other test equipment
• Identifies, reports, and negotiates problems that arise during feasibility and design verification testing, and escalates new or persistent failure modes to appropriate engineering teams
• Proactively engages with engineering teams and leads failure investigation and root cause analysis
• Clearly documents test results and observations in test reports
• Designs test fixtures and other test aids needed to perform Design Verification and Life/Reliability tests
• Engages with design and test engineers to identify and develop processes and test methods that could benefit from new or updated fixture designs

Qualifications

• Minimum of 6+ years experience working in an engineering or research team environment
• Minimum BS in Mechanical, Biomedical Engineering or similar degree. MS preferred
• Medical Device Verification/Validation experience is required
• Understanding of design controls used in the Medical device development is required
• Ability to perform mechanical engineering calculations needed to support equipment design, including dimensional analysis
• Experience using tools and measuring equipment (Force Gauge, Calipers, Instron, Oscilloscopes etc.)
• Ability to work independently and with minimal supervision
• Ability to multitask, and handle tasks with competing priorities effectively
• Ability to work with biological samples, including blood, tissue and organs
• Familiar with GDP skills
• Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others

Skills and Experience

• Prefer experience within medical device or pharmaceutical industry
• Experience with working through various phases of medical device product development process (concept through launch) is preferred
• Experience with SolidWorks or similar CAD software
• Experience with MATLAB, Python, Arduino is highly preferred
• Experience working with electro-mechanical systems is a plus
• Experience with Test Method Validation is highly preferred
• Experience in Reliability Engineering is a plus