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Katalyst Healthcares & Life Sciences is hiring: Technical Writer- Medical Device

Katalyst Healthcares & Life Sciences
Wilmington, DE Full Time
POSTED ON 1/16/2025
AVAILABLE BEFORE 4/9/2025

Job Description

Title : Technical Writer - Medical Device

Location : Danvers, MA

Duration : 6 Months

Interview : Phone and Face to Face

Important Skills : This role is to perform all the write-up for formal verification and validation testing. This includes plans, protocols, reports, and engineering summaries, and IQOQ’s. An engineering background is preferred as the candidate might be pulled into the lab to help support some mechanical testing if needed.

Principal Duties and Responsibilities :

  • Develop and update process documentation including assembly procedures, test procedures, routers, travelers, BOMs, process flows, and process FMEAs.
  • Assist the engineering team to qualify and optimize processes and tooling via IQ / OQ / PQ, preventive maintenance, Gage R&R Studies, and Process Capability Studies.
  • Maintain accurate documentation of concepts, designs, and processes while keeping current knowledge of medical, technical, and biomedical developments related to company products.
  • Ability to work in cross-functional teams that span global operations. Proficient in English and German verbal and written communication. Must enjoy a team approach over individual contributions.
  • Regularly report on project status and schedule progress.

Job Qualifications :

  • Bachelor's degree required in life sciences and / or writing; medical device experience preferred.
  • 2 to 5 years of related engineering experience required.
  • Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and internationally.
  • Must be proficient in Microsoft Office Suite; working knowledge of SAP desired.
  • Additional Information

    All your information will be kept confidential according to EEO guidelines.

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