Location: Fridley, MN
Duration: 12 Months
Job Responsibilities
- The Technical Writer will develop complex technical materials (labeling) that instruct users in the safe and proper use of Neuromodulation products and therapies.
- The audiences for these materials include physicians, nurses, hospital technicians, and patients.
- Plan, research, develop, and write medical device labeling, and manage labeling deliverables as part of cross-functional project teams under general supervision.
- Simultaneously manage up to two labeling updates and one small, new-product-introduction project that involves multiple labeling pieces.
- Understand and adhere to all quality management system documents and product commercialization procedures applicable to labeling development.
- Research and write requirements used to create labeling content, and write requirement trace reports.
- Assist in providing documentation for CAPAs, and departmental and business-unit audits.
- Contribute to time and cost estimates for labeling deliverables for project teams.
- Develop illustrations in cooperation with professional illustrators.
- Participate on department and business-unit initiatives.
- Oversee Engineering Change Order process for labeling, including writing change control plans and presenting to the Change Control Board.
- Coordinate translations with Medtronic Translations and track the status of translations.
- Prepare and occasionally present documentation for product issue escalation events, deviations and functional reviews.
- Complete labeling proofs, develop documentation for regulatory submissions, and carry out other tasks as assigned.
Minimum Qualifications
- BA/BS in Technical Communications, English, Journalism, or related field and 1-4 years of writing experience, or MA/MS in Technical Communications, English, Journalism, or related field.
- Desired/Preferred Experience working in a regulated environment.
- Excellent written & oral communication skills
- Excellent interviewing & facilitation skills
- Project management experience.
- Experience working in an engineering environment.
- Experience writing in XML publishing systems
- Experience working with international standards.
- Experience with writing for translations in an international organization, or exposure to the elements of writing for translations.
- Experience working with human factors and involvement with human factors studies.
- Experience with writing manuals for complex hardware and software systems.
- Coursework in graphic design, human factors, electronics, biology, anatomy, or physiology.
- Understanding of manufacturing documentation and product-lifecycle systems.
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