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Design Quality Engineer

Job in Warsaw, Kosciusko County, Indiana, 46580, USA
Listing for: Katalyst Healthcares & Life Sciences
Full Time position
Listed on 2026-08-05
Job specializations:
  • Engineering
    Quality Engineering, Biomedical Engineer
Job Description & How to Apply Below

Design Quality Engineer

Location:

Warsaw, IN (On-Site) Must have Medical Devices Exp.

Job Description:

  • Strong creative, analytical and problem-solving skills.
  • Process experience, ability to observe and understand manufacturing processes.
  • Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software
  • Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)
  • Good experience in Validation (IQ, OQ & PQ).
  • Ability to read engineering drawings, GD&T, terminology, schematics.
  • In-depth knowledge of design of medical devices preferred.

Roles & Responsibilities:

  • The candidate will need to have effective communication skills and be a team player to work with globally located client cross-functional teams to execute and deliver as per projects requirements.
  • The candidate will be responsible for the following.
  • Driving and supporting design quality activities for multiple new product development projects
  • Completing and approving verification and validation activities.
  • Time Savor Fluid change validation, New Silkscreen ink
  • Creating, updating, reviewing risk management report, DFMEA

Required:

  • 5+ years of medical device industry experience in NPD Engineering and Design Quality.
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