Technical Writer

Insight Global; Arden Hills (MN); On-site; USD 47,000 - 55,000; Part time

Job summary

Insight Global is seeking a Technical Writer II to develop, edit, and maintain high-quality Instructions for Use and labeling for clinician and patient use. The role emphasizes clarity, regulatory compliance, and collaboration with engineering, QA, regulatory, and marketing teams to ensure accuracy and safety.

Qualifications

• Bachelor's degree in Technical Communication, English, Biomedical Engineering, or Life Science.
• Minimum of 2+ years of technical writing in a regulated medical/manufacturing environment.
• Proficiency with MS Office, Adobe Creative Suite, Content Management and Quality Management Systems.

Responsibilities

• Write and edit clinician IFUs, patient manuals, and product labels.
• Lead document reviews with engineering, quality, regulatory and other teams to ensure accuracy and compliance.
• Ensure materials meet FDA, ISO and EU MDR requirements.
• Maintain revision histories and supporting documentation for risk management.

Skills

Attention to detail

Cross functional communication

Regulatory awareness

Critical thinking

Education

Bachelor's degree in Technical Communication, English, Biomedical Engineering, or Life Science

Tools

MS Office

Adobe Creative Suite

CMS

QMS

Job description

Duration: 12 months with possible conversion

Compensation: $34-$40 hourly rate

Job Description

Our client is looking for a Technical Writer II to join a leading medical device manufacturing company to be 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.

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.

Required Skills & 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 Skills & 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