Location: Fridley, MN
Duration: 12+ months
Position Description
POSITION DESCRIPTION:
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.
POSITION RESPONSIBILITIES:
- 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 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.
BASIC QUALIFICATIONS:
- BA/BS in Technical Communications, English, Journalism, or related field and 1+ years of writing experience, or MA/MS in Technical Communications, English, Journalism, or related field.
DESIRED/PREFERRED QUALIFICATIONS
- MA/MS in Communications, English, Journalism, or Scientific/Technical Communications.
- 2+ years of job-related experience.
- Experience developing technical manuals in a regulated environment.
- Cross-functional project management experience.
- Experience working in an engineering environment.
- Experience writing in XML publishing systems.
- Experience interpreting international standards.
- Experience with writing for translations in an international organization.
- Experience working with human factors and involvement with human factors studies.
- Experience with writing manuals for complex hardware and software systems.
- Coursework or experience working in the fields of graphic design, human factors, electronics, biology, anatomy, or physiology.
- Experience working with manufacturing documentation and product-lifecycle systems.
- Experience working in a highly regulated environment.
- Experience working for a medical device or pharmaceutical company.
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