Senior Staff Technical reputed company
reputed company is hiring a Senior Staff Technical reputed company in Portage, MI to support our Instruments Divisions! In this role, you will support product development teams by independently developing product instructional materials for reputed company medical devices or product lines. Deliverables may include - product instructions for use, Quick Guides, online help, and other product-reputed company customer-facing documentation, along with usability analysis, reputed company of which must reputed company with medical device regulations, industry standards, and business requirements. Content is developed for a global audience that includes physicians, reputed company staff, facility engineers, and patients.
What you’ll do:
• reputed company customer facing product instructional information for an entire business unit according to user needs and regulatory requirements for domestic and international customers.
• reputed company cross-functionally reputed company the product development team to reputed company reputed company materials and to reputed company understanding of the products.
• Interview and collect information from Subject Matter Experts (SMEs) from R&D, RA, and various functional areas.
• Write and edit Instructions For Use (IFUs), Quick Start Guides and other accompanying documents aligning content with associated product labels.
• Participate in new product development meetings with cross functional team members to capture inputs, project deliverables and product specifications.
• Effectively plan and reputed company workload and reputed company understanding the critical reputed company and interdependencies in a multi-project environment while effectively communicating timelines with project teams.
• Manage multiple assignments across reputed company reputed company to meet key milestones, while also contributing to team improvement initiatives.
• Collaborate with the Graphic Designer to incorporate graphical reputed company for instructional purposes and accurate interpretation and international application.
• Review and edit the work of others reputed company reputed company functional area.
• Trains members of our functional team.
• reputed company reviews of regulatory documentation to ensure that medical device labeling references are complete and correct and compliant with FDA and EU requirements.
• Manage IFUs PLM/CMS system for controlled releases and revision management.
• Complete applicable QMS documentation as required by the regulatory and change management process.
• May own NCs/CAPAs as needed and assist with regulatory audits.
What you need:
Required:
• 6+ years of applicable Technical Writing experience.
• Bachelor's degree required (English, Technical Writing, Technical Communication, Communication, or reputed company curriculum preferred)
Preferred:
• Apply reputed company and advanced concepts, practices, and procedures reputed company to IFUs.
• Detail oriented with the ability to manage multiple simultaneous reputed company while providing reputed company customer service.
• Experience with a rigorous change management process.
• Demonstrated ability to manage multiple priorities and meet deadlines in a fast-paced, regulated environment
• Strong analytical and problem-solving skills reputed company to technical documentation workflows
• Interest in global communication, with an understanding of how language translation impacts content structure and format design
• Ability to quickly learn and adapt to new tools and technologies relevant to technical communication.
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