Intuitive Surgical Careers
Design Controls Engineer
Primary Location: United States-California-Santa Clara County-Sunnyvale
Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position:
The Design Controls Engineer plays a vital role in developing safe and effective medical devices at Intuitive Surgical. As an embedded member of the Training Technologies (R&D) team, they support the rapid and efficient development of new products, while ensuring that complete and transparent records of product designs are created. They work closely with a team of exceptionally talented engineers and design professionals developing highly innovative products for use with da Vinci surgeons and staff. The position also plans and executes test protocols for functional SW verification for the training systems. Their work helps safeguard the integrity of the design and ensures that Design History Files (DHFs) meet all regulatory requirements. The Design Controls Engineer is expected to bring to their role a passion for proper design control methodology, a strong sense of pride in their work output, and a real interest in Intuitive Surgical's technology, products, and application.
Position Roles and Responsibilities:
• Assist the new product development team with compiling and updating engineering design control documents for Design History Files, including risk analyses, requirements, and design verification and validation test documentation.• Support design team to produce high quality, consistent design documents that meet Intuitive Surgical's requirements.• Use traceability database software tool extensively to manage design control documents and the links between document content.• Design, develop, and execute test protocols for functional SW verification for intricate robotic surgical systems.• Analyze test data, identify non-conformance trends, generate concise executive summaries, and recommend design improvements.• Contribute to the assessment and verification of Simulation modules.
• Coordinate documentation and Engineering Change Orders (ECOs) related to major design reviews.• Produce requirements trace mapping and associated documentation.• Develop test protocols and execute test cases.• Log issues found within the issue tracking system; work with software and cross-functional teams to debug.• Work with SME’s to collect data for training modules.
• Master’s Degree in engineering or other technical area• Minimum 2-3 years' experience working in a regulated environment or equivalent• Experience writing and reviewing engineering (design control) documents, including specifications, test protocols and test reports• Ability to manage challenging assignments and multiple assignments in parallel• Understanding of robotic control systems and clinical use of daVinci system• Assertive, outgoing personality with an ability to work collaboratively within an engineering team• Excellent writing and communication skills, and attention to detail
• Skilled in the use of Agile or similar lifecycle management system tool• Skilled in the use of MKS, Doors or other requirements management tool• Development experience with complex systems with a combination of hardware and software• Experience in Risk Analysis and Failure Modes and Effects Analysis (FMEAs)