Gregory Ciolek
Principal Technical Writer at Stryker Instruments
- Role
- Principal Technical Writer at Stryker
- Location
- Portage, MI, US
- LinkedIn followers
- 500 followers
About Gregory Ciolek
Technical communications professional with over 30 years of experience; expertise includes technical writing, process mapping, XML/DITA publishing, enterprise content management, and electronic workflow development.Proficient at gathering requirements and applying the latest standards related to medical device labeling. Standards include those related to user documentation, product safety information, risk management, product-specific requirements, cleaning, disinfection, and sterile processing instructions, usability, human factors, and the use of symbols and colors. Specialties: Medical Device Technical Writing, Project Management, Instructional Design, Taxonomy Development, Continuous Process Improvement
Experience
Principal Technical Writer
Mar 2011 — Present · US
Kalamazoo, MI-Planning, researching and writing instruction manuals for large, multi-document projects-Supporting 510(k) and product release documentation for surgical instruments, operating room equipment, surgical navigation systems, interventional pain equipment, and biological waste management systems-Reviewing and editing documentation for accuracy, translation localization, and compliance to industry standards and regulations, including Food and Drug Administration (FDA) and Medical Device Regulation (MDR) requirements-Interfacing with engineering, marketing, quality assurance, regulatory affairs, clinical sciences, human factors engineering, industrial design, and product safety/approvals to coordinate the approval and release of documentation-Supporting performance improvement efforts to optimize internal processes, reduce translation costs, decrease development time, and improve the quality of and access to information products.
Education
Wayne State University
Awarded Bachelor of Arts Degree in English, Technical and Professional Writing
1977 — 1986
Community College of the Air Force
Awarded Associate Degree in Applied Science, Avionics Systems Technology
1981 — 1985
Northern Illinois University
Awarded Master of Science Degree in Education, Instructional Technology
1996 — 2000
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