• 12 Month contract opportunity - W2 (No C2C)
• Compensation: $40 - $43/hr
• Onsite: 3410 Central Expressway, Santa Clara, CA, 95051

Intuitive Surgical, in cooperation with our recruitment partner Raise, are hiring. At Intuitive, we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare’s most complex challenges.

Join us in making big leaps forward for healthcare professionals and their patients. Together, let’s help to advance the world of minimally invasive care.

Primary Function of Position:

The Regulatory Post Market Surveillance Specialist – Technical Writer provides feedback to customers via Failure Analysis Letters. Feedback includes a summary of failure analysis results, Instruction For Use (IFU) reminders, and recommendations for customer consideration. Failure analysis letters can be written for all Intuitive products and platforms including the daVinci robotic assisted surgery system and Ion robotic assisted bronchoscopy system

Roles & Responsibilities:

This position has responsibility and authority for:

• Creation and distribution of failure analysis letters based on completed failure analysis results
• Managing failure analysis letters and backlog using software systems such as SAP and Trackwise
• Work with translation vendors, as required, for letters outside of US
• Provide clarification on failure analysis letter content when requested
• Escalate feedback, comments, or concerns from customers or distributors based on failure analysis letters provided to end user
• Escalate complaints to the Post Market Investigation (PMI) group as required
• Interface with Failure Analysis, Customer Service, engineering, RMA, and clinical teams to gather information required for failure analysis letter content
• Maintain library of similar responses in reference to failure modes, root cause, IFU reminders, and recommendations
• Participate in process improvement activities to continuously improve process effectiveness
• Execute on projects as required
• Perform other duties as directed

Skills, Experience, Education, & Training:

Education – English, journalism, or a communications undergraduate degree. Preferred Undergraduate degree in engineering, life science, or equivalent.

Experience – Experience with technical writing for a technical product and/or company. Preferred experience within the medical device field, with experience or exposure in the following areas:

• Experience collaborating with engineering, scientists, and other specialists
• General technical and or clinical medical device knowledge
• Knowledge and understanding with Medical Device Complaint files and quality record documentation

Skills: The following skills are required for this position:

• Demonstrate strong written and verbal communication skills
• Strong computer skills (SAP, Excel, Word, PowerPoint, database)
• Efficient independent worker with ability to focus
• Attention to detail
• Demonstrate cross functional communication skills in email and in person
• Excellent organizational and analytical skills
• Ability to handle and manage workload independently
• Prioritize numerous activities in a rapid paced environment
• Contribute to team oriented tasks
• Strong analytical skills
• Strong interpersonal and decision making skills.

Competency / Training: The following competencies are essential for this position:

• Having the ability to devote time and energy to the vital activities that will make a significant impact or difference
• General understanding of technical writing and ability to simplify complex topics.
• General understanding of quality records requirements and how they apply to complaint files.
• Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.

Please note that this is a contract role providing services to Intuitive through our direct sourcing partner, Raise who manages Intuitive’s Contractor Talent Community. If you are selected for this role, you will be employed by Raise and will not be an employee of Intuitive.

Work with an Award Winning Employer:

• Best Places to Work, Glassdoor Employees’ Choice, 2019 (#12 of 100), 2020 (#7 of 100)
• America’s Best Midsized Employers, Forbes, 2019 (#149 of 500)
• Top 150 Places to Work in Healthcare, Becker’s Hospital Review, 2019
• Top CEOs, Glassdoor, 2019 (#9 of 100)

Raise and Intuitive are Equal Employment Opportunity Employers. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. We will consider for employment all qualified applicants with arrest and conviction records in accordance with fair chance laws.

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