Technical Writer, Medical Devices (Hybrid - Sunnyvale)

***Please note that our customer is currently not considering applicants from the following locations: Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, and Tennessee.***

Our Customer is a corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery. Founded in 1995, their goal was to create innovative, robotic-assisted systems that help empower doctors and hospitals to make surgery less invasive than an open approach. Working with the top medical professionals, they continue to develop new, minimally invasive surgical platforms and future diagnostic tools to help solve complex healthcare challenges around the world.

We are seeking a Technical Writer on a contract basis to help support our Customer's business needs. This role is hybrid (2 days onsite 3 days remote/week) in Sunnyvale, CA.

This role will produce accurate, clear, and consistent instructions for use (IFU) for medical device robotic assisted systems and instruments; receive basic instruction on day-to-day work and general instructions on new assignments; can be mentored by a more experienced writer; apply basic professional concepts and skills; learn and understand company policies and procedures to resolve challenges.

• Collaborate with cross-functional Subject Matter Experts (SMEs) to research and develop content for instructions for use.
• Plan, write, and edit instructions for use for medical device systems, instruments, and software using Adobe FrameMaker or extensible markup language (XML) and Darwin Information Typing Architecture (DITA).
• Follow Good Documentation Practices and change control guidelines for a regulated industry.
• Work with Regulatory experts on submission deadlines and requirements.
• Complete documentation control steps to release final documentation. This includes Change Orders in the documentation control system.
• Conduct validation and verification of technical documentation.
• Represent department as back-up team member on product development core teams.
• Keep abreast of basic requirements for compliance in own area of work and comply with those requirements. Participate as required in training on regulatory issues affecting own area of work. Escalate regulatory compliance questions/issues to the attention of management.
• Participate in training and hands-on demos (in person) to learn the products you are writing about.

• Bachelor’s degree in technical writing, communications, professional writing, English, or equivalent experience preferred.
• Certificate in technical writing desirable.
• 2 to 5 years as a writer in a technical or medical device/life science/regulated environment, or equivalent experience preferred.
• Verbal communication skills that include responding calmly under pressure and leading content review meetings with multiple SMEs.
• Required skills:
• DITA/Oxygen
• Medical device or regulated background
• Ability to thrive in fast paced environment
• Basic knowledge of XML, Darwin Information Typing Architecture (DITA).