KARL STORZ Endoscopy America, Inc. Regulatory Affairs Technical Writer in El Segundo, California
KARL STORZ Endoscopy-America, Inc., is an affiliate of KARL STORZ SE & Co. KG, an international leader for more than 70 years in reusable endoscope technology, encompassing all endoscopic specialties. Based in Tuttlingen, Germany, KARL STORZ SE & Co. KG is a family-owned company that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship and clinical effectiveness.
Headquartered in El Segundo, California, KSEA is responsible for all U.S. distribution of endoscopes, instruments, imaging systems, electromechanical devices and OR1® integration technologies.
The RA Technical Writer will write and revise user manuals, instructions for use, and related user product instructions for medical devices and equipment; interview subject matter experts; research and analyze product documentation and clearly present findings; ensure consistency between user product instructions. The Writer will also keep track of comments made in meetings and emails about content of user product instructions and be able to retrieve that information in the future.
REQUIRED EDUCATION/TRAINING and/or EXPERIENCE:
- 3+ years of relevant experience or equivalent combination of education and work experience.
- Expert knowledge of advanced features of Microsoft Word
- Proficient in Microsoft Excel
- Proficient in Adobe Acrobat and InDesign
- Familiar with PowerPoint, Visio, and One2Edit software.
- Familiar with document management systems.
- Experience working with regulated medical documentation.
REQUIRED KNOWLEDGE AND SKILLS:
- Able to interview all levels of subject matter experts to obtain the appropriate information needed for user product documentation
- Able to write documentation in a manner that users with limited to highly proficient technical product knowledge can understand.
- Excellent English, spelling, and grammar skills and able to write clear, concise instructions in a logical sequence.
- Able to review and edit content to ensure consistency and compliance with internal style guides, trademark usage, and other documentation standards
- Able to write for translatability.
- Able to develop new documentation that is similar to existing documentation and able to recommend entirely new documentation layouts
- Able to manage and meet multiple project deliverables and deadlines
- Well organized, thorough, and detailed oriented
- Good research, information gathering, and analytical skills
- Able to adapt to a fast-paced, changing environment
- Able to analyze project scope, setting interim deadlines for documentation development.
- Able to work independently and manage time effectively
- Able to make decisions, exhibit sound and accurate judgment, support and explain the reasoning for decisions, and include the appropriate people in the decision-making process
KARL STORZ reserves the right to change or modify the employee’s job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employee must comply will all applicable KARL STORZ policies and procedures.
KSEA provides equal employment opportunities (EEO) to all applicants without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, KSEA complies with applicable state and local laws governing non-discrimination in employment.
Location: El Segundo, CA
Job Code: 9148
Employment Duration: Employee Full Time