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Engineering - Technical Writer

2 months ago

Minneapolis, United States Planet Pharma Full time

Engineering - Technical Writer

CONTRACT through 4/25/25 - extendable

Open on pay rate depending on education and experience - $28 - $45 per hr

Minneapolis, MN - onsite 1-2 days per week


Typical responsibilities may include:

  • Manage all aspects of document development and assist in production release, including draft reviews and formal labeling approvals, coordination of translations, and initiating CO/CA release.
  • Revise, edit, and format legacy product documentation as required, including but not limited to user’s guides, service manuals, instructions for providers (IFPs), and instructions for use (IFUs).
  • Ensure compliance of labeling with all applicable regulatory/QSR requirements.
  • Create, edit, and format documentation as part of the compliance with requirements from the European Union (EU Medical Device Regulation).
  • Deliver supporting documentation to the labeling product, including labeling design plans, trace documents, technical reviews and verification deliverables.
  • Effectively manage multiple projects, changes in project scope, and shifting priorities to maintain project requirements and ensure deadlines are met.
  • Collaborate with departmental and cross-functional peers to ensure proper resolution to questions and issues during the document development process.
  • Continually review the document development process to ensure quality in labeling output.


REQUIRMENTS:

  • Around 2-5 years of related technical writing experience REQUIRED
  • Experience in the medical device industry preferred


Nice to Have:

  • Experience working in a federally regulated environment (FDA)
  • Experience with the European Union Medical Device Regulation (EUMDR)
  • Familiarity with Quality/CAPA processes and principals
  • Self-directed and highly organized
  • Ability to manage multiple priorities
  • Excellent communication skills
  • Advanced writing/editing skills
  • Cross-functional collaborative nature
  • Product Lifecycle Management software experience
  • Medical terminology experience
  • Familiar with the principals of neuromodulation
  • Product development workflow