Program Manager
Primary Location: United States-California-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 183198
Description
Company Description:
Intuitive Surgical: What Matters
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.
Role and responsibilities:
Driving the New Product Development (NPD) activities related to Software supporting CFDA submission
• Draft product technical requirements (PTR) and technical files related to software for CFDA submission
• Train Joint Venture (JV) personnel on all aspects related to software
• Interface with US and JV teams to create requirement documents and test protocols is support of CFDA submission;
• Support all design & change control activities related software based on CFDA regulations
• Support China specific changes to the Ion product to meet local regulatory requirements and standards
• Communicate status cross-functionally and provide clear communication to the organization on project status, critical path, as well as potential areas of risk
• Work closely with Product Development, Manufacturing, Marketing, and Quality organizations to ensure input and representation in the development process
• Organize and lead project review meetings; create and maintain project schedules
Qualifications:
• PhD (preferred) or MS in software with minimum 10 years of experience
• C/C++ and Matlab programming skills, as well as hardware, software, and mechanism
Integration skills. Knowledge of Python would be a plus.
• Knowledge of electrical and mechanical design principles and CAD tools is a plus.
• Excellent verbal and written communication skills with the ability to clearly present designs to larger groups
• Experience with designing software products in FDA and CFDA regulated industry or for mission critical applications is desired
• Comfort and familiarity with concepts of design input, design output, traceability, and risk analysis
• Experience in writing and executing effective test plans and protocol development is preferred
• Experience with submitting med devices to CFDA a strong plus
• Able to work in both US and China up to 30% travel
• Fluent in mandarin (read/write) a strong plus
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.