Technical Writer (m/w/d)
Our customers software engineering team in Germany needs a Technical Writer. The engineering team needs to deliver documentation for the Software as Medical Device (SaMD), including software development plans, software architecture documents, software detailed description, SOUP assessment, testing reports, release notes, and other engineering/technical documents required for regulatory submission. All documentation is written in English, needs to be discussed in English, and then routed for approvals through our systems. We expect the technical writer to be native English speaker, bilingual, or at least proficient in technical conversation. Residence in Germany.
As a Technical Writer you will be a key member of a team delivering cutting edge Digital Surgery software. The software is considered a medical device, and supports surgeons pre- and intra-operative. Therefore, the documentation follows the standards for medical device manufacturing. Your direct responsibility will be to support engineering teams in writing technical documentation, discussing the content with cross-functional stakeholders, and managing the approval and document release process.
Das dürfen Sie erwarten
- Attractive salary based on the BAP/DGB collective agreement
- Guaranteed punctual payment, possibility of installments
- Up to 30 days vacation per year
- Representation of interests by a comprehensive works council
- Free online courses, e.g. "German as a foreign language"
- Use of the Randstad App (leave requests online, payroll viewable at any time and much more)
- Work closely with software engineering, program management, regulatory affairs, and quality assurance teams to understand the requirements towards documentation
- Ability to communicate technical information (software) in a clear consistent manner is required
- Lead documentation review and incorporate cross-functional feedback
- Lead the generation of documentation based on inputs from software engineering teams
- Work independently and with foresight to move documentation to release
- Ability to communicate technical information in a clear consistent manner is required
- Experience with medical device documentation and design history files
- Experience with technical documentation for regulatory submission
- Preferred software engineering background
- Preferred experience with Oracle Agile PLM for record release and management
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