Staff Technical Writer

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 development process related to content.
• Continually review the document development process to ensure quality in labeling output.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Mentor other technical writers within the team.
• Engage in global strategies to develop a single process for labelling and documentation.

Job Qualifications

Required:

• Bachelor’s degree in a technical field or similar work experience with a degree in English.
• Minimum 9 years of related experience or 8 years with MS or 5 years with a PhD.

Preferred:

• Competency in leading technical documentation efforts, through all phases of product development, as required.
• Experience developing documentation and labelling through a Phase Gate process as a Core Team member is highly preferred.
• Experience developing disposable medical devices documentation.
• Experience and or working knowledge of documenting capital equipment.
• Extensive working knowledge of, medical device regulatory standards: - 820-CFR, ISO-13485, IEC60601, QSR, etc. is required.  
• Proficient in Microsoft Windows Office applications including MS Outlook, MS Powerpoint, MS Project, Visio, etc.
• Self-motivated, engaged, and productive.
• Must be able to solve complex and/or ambiguous problems using good judgement related to documentation as well as logical and systematic thinking. 
• Must be able to use good judgement in making timely decisions. Able to balance risk vs. benefits in a variety of situations. 
• Must be able to document design failure modes, plan for design assurance testing, and proactively implement contingency plans as necessary.
• Must be able to collaborate effectively with others, work well within cross-functional teams and across multiple sites, as applicable.
• Must be able to drive for results.
• Must be able to communicate effectively at all levels, both verbally and in writing. Strong presentation skills and the ability influence.
• Able to predict and manage the expectations of project stakeholders.
• Inspires and motivates others and provides work direction.
• A positive “Can Do” attitude.