Technical Writer (Sunnyvale, CA)

***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 support our Customer's business needs. This role is on-site in Sunnyvale, CA.

This role will produce accurate, clearly presented, consistent instructions for use (IFU) for medical device robotic systems and instruments; receive general instructions on day-to-day work and general instructions on new assignments; be mentored by a more experienced writer; use professional concepts and skills; and apply company policies and procedures to resolve a variety of issues.

Responsibilities:

• Plan, write, and edit instructions for use (IFU) for medical device systems and instruments, including large system manuals, instrument manuals, and ship-with literature using Adobe FrameMaker, Adobe InDesign, or extensible markup language (XML)
• Collaborate with department team members and with cross-functional team Subject Matter Experts (SMEs) to research and develop content for instructions for use and validate content.
• Own document creation from inception to completion
• Work to ensure compliance with FDA and regulatory guidelines.
• Work with interaction designers and technical illustrators to develop documentation images, including raster and vector images.
• Conduct validation and verification of technical documentation
• Understand documentation control steps to release final documentation.
• May participate in product development core teams as a representative for technical publications.
• Serve as lead writer on projects and mentor other writers.
• Keep abreast of the 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 and share learned expertise with others. Bring regulatory compliance questions/issues to the attention of management.
• Adhere to policies, procedures, and quality documents. Collaborate with project team members to share knowledge and best practices.

Qualifications

• Bachelor’s degree in technical writing, communications, professional writing, English, or equivalent experience preferred. A certificate in technical writing is desirable.
• 5 to 8 years of technical writing experience in a hardware, software, biotechnology, or medical environment, including documentation for a highly technical audience.
• Strong experience with current versions of standard authoring tools, including Adobe FrameMaker or Adobe InDesign, and Adobe Acrobat, preferred.
• Working knowledge of Adobe Illustrator, Adobe Photoshop, or equivalent is desirable
• Excellent communication skills required.
• Strong writing and grammar skills in areas of content development and writing style. Analytical ability to swiftly grasp and effectively communicate complex scientific and engineering concepts.
• Organizational skills and ability to manage deliverables under tight deadlines, set priorities, and manage time effectively.
• Familiarity with XML, Darwin Information Typing Architecture (DITA), and content management systems strongly preferred.
• Software skills that include troubleshooting moderate FrameMaker and InDesign issues; updating or improving an existing document template; troubleshooting online help software errors with minimal assistance; creating error-free PDF files.
• Verbal communication skills that include responding calmly under pressure and leading content review meetings that result in document approval.

We offer a competitive salary range for this position. Most candidates who join our team are hired at the median of this range, ensuring fair and equitable compensation based on experience and qualifications.

Contractor benefits are available through our 3rd Party Employer of Record (Available upon completion of waiting period for eligible engagements) Benefits include: Medical, Dental, Vision, 401k.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.