Job Description
Position Summary
Develop and release product labeling documents (including operating manuals, user guides, service manuals, and various other guides) and supporting documents (which may include design history file documentation) for electro-mechanical serialized medical equipment and network applications/software products. Must be knowledgeable of effective writing styles and the correct use of English in order to translate technologically complex concepts into easy-to-understand language.
Essential Duties & Responsibilities
- Translates requirements into appropriate content that complies with FDA and other governmental agency regulations.
- Interacts with project team personnel (including Engineering, Medical, Marketing, and Regulatory) to obtain technical information needed to create content.
- Ensures technical writing outputs adhere to departmental standards and practices.
- Coordinates and obtains necessary approvals for release of documentation.
- Must be able work on several projects concurrently, ensuring timely completion of each.
- May support design history file documentation in the role of author or editor.
Knowledge, Skills & Qualifications
- Ability to write in accordance with current technical writing principles and to follow corporate and departmental processes with limited guidance.
- Strong writing, editing, and proofreading skills.
- Advanced knowledge of Adobe FrameMaker 10 or later (required for labeling documents).
- Advanced knowledge of Microsoft Word.
- Working knowledge of Adobe Acrobat.
- Working knowledge of image editing software is desirable (to make minor adjustments to existing graphics or screen captures).
Education And Experience
- Must be at least 18 years of age
- Associate Degree or comparable college-level coursework required, preferably in English, Communications, Journalism, or a related field. Bachelor’s Degree or commensurate experience preferred.
- Minimum 5 years of technical writing experience required.
- Experience in FDA-regulated environment preferred.
Physical Requirements And Work Environment
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- Typically requires travel less than 5% of the time
About Us
ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.
With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.
We're Ready To Bring You Consistent Quality, Innovation, And Value In More Areas Than Ever. Our Focus Allows Us To Bring You
- Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
- The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
- IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
- Significant US IV solutions manufacturing and supply capabilities.
ICU Medical EEO Statement
ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.
ICU Medical EEO Policy Statement
Know Your Rights: Workplace Discrimination is Illegal Poster
ICU Medical CCPA Notice to Job Applicants
