Hybrid Technical Writer II — Medical Device Documentation

Boston Scientific

Arden Hills (MN)

Hybrid

USD 60,000 - 114,000

Full time

2 days ago
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Job summary

Boston Scientific is seeking a Technical Writer II to develop, edit and maintain high-quality instructions for use (IFUs), patient manuals and product labels. You’ll translate complex technical information for clinicians and patients while ensuring regulatory compliance across FDA, ISO and EU MDR standards.

The role requires collaboration with engineering, quality, regulatory and manufacturing teams. A hybrid work model is in place, with at least three days in the local office to support timely,

Qualifications

  • Bachelor’s degree in technical communication or related field.
  • 2+ years’ experience in technical writing within regulated medical/manufacturing.
  • Proficiency in MS Office and Adobe Creative Suite.
  • Ability to simplify complex technical and medical information.
  • Collaborate across functions and communicate clearly.

Responsibilities

  • Develop, write, edit and maintain IFUs, manuals and product labels.
  • Translate technical and clinical information for clinician/patient audiences.
  • Lead cross-functional documentation reviews for regulatory compliance.
  • Ensure alignment with FDA, ISO and EU MDR requirements.
  • Maintain revision histories and document traceability.
  • Plan and manage documentation projects and timelines.
  • Balance multiple projects while upholding quality and consistency.
  • Communicate with stakeholders to resolve documentation questions.

Skills

Strong writing
Editing
Communication
Cross-functional collaboration
Attention to detail
Problem solving

Education

Bachelor's degree in technical communication, English, biomedical engineering, life sciences or related

Tools

MS Office
Adobe Creative Suite
Content Management Systems
Quality Management Systems (QMS)

Job description

Boston Scientific is seeking a Technical Writer II to develop, edit and maintain high-quality instructions for use (IFUs), patient manuals and product labels. You’ll translate complex technical information for clinicians and patients while ensuring regulatory compliance across FDA, ISO and EU MDR standards.

The role requires collaboration with engineering, quality, regulatory and manufacturing teams. A hybrid work model is in place, with at least three days in the local office to support timely,

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