Technical Writer

Role                  :             Technical Writer II

Location            :             Rochester, MN

Duration            :            12+ Month Contract

Job Summary:

The Technical Writer II is responsible for developing, editing, and maintaining high-quality Instructions for Use (IFUs) and labels that support clinician use, patient safety, and regulatory compliance. The ideal candidate is detail-oriented, collaborative, and skilled at translating complex technical information into clear, user-focused content.

Key Responsibilities
•Writing: Exceptional writing and communication skills.
•Document Authoring: Create and update clinician IFUs, patient manuals, and product labels.
•Cross-Functional Collaboration: Lead documentation reviews with engineering, quality, clinical, regulatory, marketing, and manufacturing teams to ensure technical accuracy and regulatory compliance.
•Regulatory Compliance: Ensure all materials conform to strict standards including FDA guidelines, ISO norms, and EU MDR requirements.
•Document Control: Create and maintain precise revision histories and supporting documentation for risk management.
•Project Management: Create and adhere to project plans for document completion. Manage multiple projects simultaneously as required.

Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Required Qualifications:
•Education: Bachelor's degree in Technical Communication, English, Biomedical Engineering, or a Life Science discipline.
•Experience: Minimum of 2+ years of technical writing experience within a regulated, medical, or manufacturing environment.
•Technical Proficiency: Mastery of tools like Microsoft Office Suite, Adobe Creative Suite, and experience using Content Management and Quality Management Systems.
•Core Competencies: Exceptional eye for detail, critical thinking, strong cross-functional communication skills, maintenance of effective relationships with subject matter experts, and the ability to simplify dense terminology.

Preferred Qualifications:
•Advanced degree in technical communications, English or similar
•Document creation using an XML-based content management system
•Writing for multiple audiences (clinicians and patients)
•Strong attention to detail
•Knowledge of medical terminology and anatomy
•Proven understanding of literature and labeling development in a heavily-regulated environment
•Use of critical-thinking and problem-solving skills to identify risk and develop creative solutions