Technical Writer

vor 1 Woche

Melbourne, Österreich First Line Software, Inc Vollzeit

At First Line Software we're creating a better world by finding innovative solutions to the problems people face every day.
Where most see a setback, we see possibility.
And we're looking for teammates who feel this way, too.

We've established a network of over 500 teammates spread across the United States, Europe, Latin America, Australia, and India.
As our international team grows, we're on the lookout for like-minded professionals who want to share their expertise and put something good out into the world.
Are you up for the challenge?

The project and your roleAs a Technical Writer specializing in Design Control for a project within the medical devices sphere, your role will involve creating robust documentation, developing training materials, and establishing best practices for efficient and compliant product development processes.
You will collaborate closely with various teams to ensure that Design Control procedures are accurately documented and communicated effectively throughout the organization.
Additionally, this position is not only about pure tech writing but also about establishing the structure and templates for the whole company's usage.
In this position you will have to structure and organize the templates used in the company to write project documentation (from project start to release).
You will interact with the quality assurance and compliance departments for medical devices to standardize and reduce the number of existing templates, which may currently duplicate each other, using best practices.
You will also work with stakeholders to interview them and create the updated template base.
Your responsibilities:Design and implement training content for internal staff on Design Control processes and documentation best practices in alignment with regulatory requirements.Generate comprehensive documentation templates for Design Input/Output, Risk Management, Verification/Validation protocols, and other key Design Control documents.Work closely with subject matter experts to gather technical information and translate complex concepts into user-friendly training materials and procedural documents.Develop examples and case studies illustrating best practices in Design Control documentation to streamline product development and ensure adherence to quality standards.Maintain a repository of training resources, best practice examples, and document templates to support ongoing Design Control activities within the organization.Structure and organize the templates used for project documentation.Interact with quality assurance and compliance departments to standardize and streamline templates.Interview stakeholders to update and create a comprehensive template base.Comply with all safety policies, practices and procedures.Report all unsafe activities to supervisor and/or Human Resources.Participate in proactive team efforts to achieve departmental and company goals.Perform other duties as assigned.Bachelor's degree in technical writing, engineering, or a related field.Proven experience in developing training content and documentation for Design Control processes in the medical device industry.Thorough understanding of regulations, ISO standards, and best practices in Design Control documentation.Expert ability to create structures and processes necessary to deliver enterprise programs/projects and/or new products to successful implementation.Proficiency in creating engaging and informative training materials, examples, and procedural documents.Strong communication skills and the ability to collaborate effectively with cross-functional teams.Familiarity with document management tools, eLearning platforms, and instructional design principles.What we can offerOur modern stack projects are the right mix of exciting and challenging;Gain access to our diverse range of training programs, courses, and certifications;Enhance your language skills with our corporate English classes;Similar open positionsInContact Administrator |
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