Intuitive Surgical Careers

Design Controls Systems Engineer

US-CA-Sunnyvale, California

Job Description

Job: Engineering
Primary Location: United States-California-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 180585


Company Description:

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:

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

Skill/Job Requirements:

• Understanding of Medical Devices Design Controls regulations (FDA CFR/QSIT, MDR, ISO 13485, ISO 14971)
• Experience with training and adoption of new process and tools including large organizations
• Database architecture and design strategy
• Requirements Management excellence including training others how to translate technical details into unambiguous, testable, reusable requirements and specifications
• Strong communicator and relationship builder
• Passion for helping teams efficiently create fully documented, robust, and reliable medical devices
• Detail-oriented and Quality focused
• Data governance oversight without rigidity
• Excellent investigative skills
• Ability to recognize and facilitate/orchestrate cross project sharing of common data (reuse)
• Bachelor’s Degree required. Master’s degree preferred.
• 5+ years of previous related experience in medical device development, requirements management, test management, and/or regulatory documentation
• Understanding of multiple technology areas (software, mechanical, electrical, biomedical, clinical, robotics, test automation, etc)
• Additional specialized training in a discipline such as software engineering, test engineering, quality, risk management, or regulatory compliance.
• Software script writing (Python, Javascript, SQL, C) highly desirable
• Experience with Application Lifecycle Management tools (Siemens Polarion, PTC Integrity, Doors)
• Excellent verbal and written communication skills
• Excellent planning and time management skills
• Highly proficient in Word, Excel, Visio, and PowerPoint
• Video training experience desirable
• Proficiency in Oracle/Agile helpful

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

We are an AA/EEO/Veterans/Disabled employer. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.