Senior Technical Writer

Contract : 7 -12 month

Location : Sunnyvale, CA 95051

Department: Technical Publications
Reports to: Supervisor/Manager, Technical Publications
 

 

Primary Function of Position:
Produce accurate, clearly presented, consistent instructions for use (IFU) for medical device robotic 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; use professional concepts and skills; apply company policies and procedures to resolve a variety of issues.

Roles & Responsibilities:

• Work with interaction designers and engineers to develop appropriate content that is easy for the end user to understand and is compliant with all regulatory guidelines.
• Work with Regulatory team on submission deadlines and requirements
• Complete documentation control steps to release final documentation. This includes Engineering Change Order (ECO) work in a 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.

Skills, Experience, Education, & Training:

• 2 to 5 years as a writer in a technical or medical device/life science environment, or equivalent experience preferred.
• Bachelor’s degree in communications, professional writing, English, or equivalent experience preferred. 
• Certificate in technical writing desirable.
• Verbal communication skills that include responding calmly under pressure; leading content review meetings that result in document approval.
• Software skills that include troubleshooting simple FrameMaker and InDesign issues; updating or improving an existing document template; troubleshooting online help software errors with minimal assistance; creating error-free PDF files
• Demonstrating basic skill in a component Content Management System (cCMS) a plus.
• Writing samples required.
• DITA experience preferred. 
• Experience in a regulated environment preferred.

Company Description:

 

LS Solutions is a privately owned minority certified niche consulting and managed solutions firm head quartered in Princeton, NJ servicing Life Sciences industry with international office locations in India, Singapore, Germany, Belgium and United Kingdom.