Staff Technical Writer

Working Location: MASSACHUSETTS, WESTBOROUGH 

Workplace Flexibility: Hybrid

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus.

 

**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

 

 

Job Description

NOTE:  The role of Staff Engineers within Olympus’s career ladder is between Sr. Engineer and Principal Eng.

The Staff Technical Writer is responsible for all aspects of documenting all related documentation and labelling required to release a project, acting as a individual contributor, or where applicable, as a Core Team Member.  In this role, the Staff Technical Writer will execute all aspects of documenting all labelling deliverables for Olympus’s U.S. Development Centre. In this dynamic role, the Staff will have the ability to work on a variety of products, with successful product launches with related documentation over time and as project demands warrant. The Staff Technical Writer will lead or contribute to efforts to define documentation related to the product requirements, collaborate with project managers and other Core Team Members on project execution strategy, timelines and cost. All documentation and labelling shall be generated utilizing design controls.

Job Duties

• Support the production of customer facing product documentation, including but not limited to: quick user’s guides and instructions for use (IFUs).
• This includes labeling for both clinicians and patients that accompany medical device products that conform to the Olympus documentation and quality assurance standards.
• Projects include R&D new product development as well as sustaining activities/legacy document maintenance for various products produced by the Olympus OSTA team.
• You will collect inputs from cross-functional technical staff to gather data for documentation, as well as research and translate technical information into manuals and/or web-based documents for non-technical and technical users.
• Responsible for supporting documentation to the customer-facing literature which may include labeling design plans, trace documents, technical reviews and verification deliverables.
• You will support product documentation updates to comply with EUMDR, FDA and other regulatory body requirements by incorporating customer inputs and ensuring standardization of document development to comply with Olympus design standards.
• Manage all aspects of document development and assist in production release, including draft reviews and formal labeling approvals, coordination of translations, and initiating CO.
• Revise, edit, and format legacy product documentation as required, including but not limited to quick user’s guides, and instructions for use (IFUs).
• Ensure compliance of labeling with all applicable regulatory/QSR requirements.
• Create, edit, and format documentation as part of the compliance with requirements from the European Union (EU Medical Device Regulation).
• Deliver supporting documentation to the labeling product, including labeling design plans, trace documents, technical reviews and verification deliverables.
• Manage multiple projects, changes in project scope, and shifting priorities to maintain project requirements and ensure deadlines are met.
• Collaborate with extensively with the labelling team and support departments and cross-functional peers to ensure resolution to questions and issues during the document