Intuitive Surgical Careers
Design Controls Systems Engineer
Primary Location: United States-California-Santa Clara County-Sunnyvale
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Primary Function of Position:
We are seeking a Design Controls Systems Engineer to support the Intuitive Surgical team focused on new product development tools and process. The Design Controls Systems Engineer will help plan, define, develop, verify, and deploy new tools in compliance with established Design Control and business processes. The ideal candidate is quality focused with an attention to detail and a passion for helping teams innovate and deliver fully documented medical devices to market in record time. The candidate has a strong understanding of Medical Device regulations and experience implementing compliant requirements management and/or test management processes and automation tools. The position includes:
• Training/adoption across the company for Design Controls processes and tools• Design Controls process improvements and optimization• Working with cross functional teams to solve problems and execute improved tools and processes• Enterprise wide tools planning, development, verification, and support• Configuration and administration of corporate Design Controls tools• Strategy and architecture for medical device documentation including optimization for automation• User support for complex traceability reports for regulatory submissions• Developing templates and optimized workflows which improve product development productivity• Ensuring compliance with global medical device deliverables including submissions, DHF, and DHR.• Integrating Risk based approaches to Design Control