Technical Writer II, Molecular Product Labeling
Business Unit: Strategy & Innovation
Requisition Number: 222597
Primary Location: United States-California-Berkeley
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%
Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.
With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.
For more information, please visit: http://www.usa.siemens.com/healthcare
The Technical Writer II is responsible for content development of technical documentation for Molecular Diagnostic products. This position reports to the Sr. Manager of Molecular Product Labeling for the Siemens Molecular Diagnostics business.
This position is a member of the Molecular Product Labeling (MPL) group, which ensures that all product labeling requirements are met for new Molecular Diagnostic products and for existing product changes. The Technical Writer II participates in the research of technical and engineering information, including drawings, design and test specifications, product prototypes, and interviews with subject matter experts to develop content for use in customer-facing documentation and to support the Molecular Diagnostics business. He/she participates in all phases of the document development cycle, including project scope, project requirements, and documentation design. He/she facilitates communication with key stakeholders to assure timely completion of product labeling technical reviews and approvals.
This position requires an in-depth knowledge of technical writing or instructional design principles, tools, practices and procedures. Content deliverables may include product documentation, such as user manuals, instructions for use, online help, and release notes.
The successful candidate will be a quality-minded, motivated team player with effective collaboration skills, able to meet project timelines, assure compliance with regulatory requirements, and support the Siemens Healthineers business principles.
- Develop new or revised technical product content working with subject-matter experts in accordance with business area, global, and industry standards and guidances
- Follow SOPs to meet compliance requirements for all document, Quality, and MPL activities
- Independently process and interpret semi-complex information to perform important areas of standard professional level work
- Assure timely completion of MPL documentation to meet project/product requirements
- Participate in the translation process to meet localization requirements
- Perform format and proofreading reviews of product labeling per approved processes and procedures
- Other tasks as assigned by Department Manager.
Required Knowledge/Skills, Education, and Experience
- Bachelor’s degree, preferably in the life sciences or engineering, or equivalent combination of education and experience. Typically 2-5 years of successful experience in a related field and successful demonstration of Key Responsibilities and Knowledge as described within this job description.
- Agile and flexible team player with the ability to effectively cope with the challenges of meeting aggressive deadlines
- Proven ability to multitask, collaborate in cross-functional teams, and work independently
- Excellent working knowledge of English grammar, punctuation and overall writing skills, with the ability to edit content for user-facing documentation
- Critical-thinker able to address semi-complex situations, issues, and adopt a systemic view of continuous process improvement to reach goals
- Able to facilitate clear communication with stakeholders
- Understanding of regulations and guidelines governing in vitro diagnostic products, with a broad knowledge of related topics such as Quality Assurance, Manufacturing, and Product Development
- Proficient with Microsoft Word and Excel
Preferred Knowledge/Skills, Education, and Experience
- Experience in IVD or medical device writing instructions for use, hardware operation, and software procedures preferred
- Experience with Framemaker, content management systems, Documentum, SAP, and SharePoint is desirable
- Experience working within a Quality System is preferred