Documentation and Service
Documentation in English for
medical devices and software while
respecting project requirements
and documentation standards
In these assignments I wrote or edited all the material (print and
online) designed the information flow and applied applicable US
Government, ISO, DIN or EU standards to the documentation. I was
NOT the sole writer/developer for SIEBE, but did validate the
software and all documentation for ISO/DIN standards.
② Cooperate closely with
documentation managers, service
personnel, trainers, developers and
other subject matter experts
Also in these jobs, I was part of a product development team
including lab personnel, product managers, field technicians... I
developed the documentation (hardware or software) as the product
was developed, produced, tested and delivered to the client.
③ Proven experience in technical
writing for software applications,
preferably in a strong regulated
I have written for user manuals and training for four different
software product efforts in the US and Europe. I have validated
documentation and results against ISO, DIN, and EU legal
standards for documentation.
④ Familiarity with laboratory systems
I worked in a mass spectrometry lab to develop the procedures and
document the mandatory procedures for handling samples using our
metabolomics assays. I am familiar with GLP practices and Medical
Devices Directive (93/42/EEC), In Vitro Diagnostic Devices Directive
⑤ linguistic discipline; a further
education e.g. in technical
documentation is a plus
My original BA was in English (Journalism) with later certifications in
XML, DITA and membership in the Society for Technical
Communications (USA) and TEKOM in Germany for more than 10
⑥ Proven experience with Adobe
FrameMaker (structured) or a
similar authoring tool
I have worked with Adobe FM (unstructured) for more than 8 years.
I have not worked the structured FM, but know the principles.
⑦ Experience with Schema ST4 or a
I have finished training with SCHEMA ST4, but have not had a
chance to work in operations with it. This is my goal.
⑧ Enthusiasm about technical writing I have been a workshop leader for the German TEKOM since 2014
and an author of TC World articles. I thoroughly enjoy training,
teaching, and talking about the process.
to market. I worked with the lab personnel, staff scientists and the product manager to assemble and field test the product, as well as write/edit all the documentation (lab manuals, software user manuals, web and marketing support, package inserts) needed to get the product packaged and in labs worldwide. My writing/documentation work has included user manuals, installation guides, and validation instructions for both hardware and software.