Analysis Skills, Communication Skills, Computer Skills, Cross-Functional, Design Failure Mode and Effects Analysis (DFMEA), Engineering Drawing, Geometric Dimensioning and Tolerancing, Manufacturing/Industrial Processes, Medical Equipment, Microsoft Windows Operating System, Problem Solving Skills, Process Validation, Product Development, Quality Engineering, Risk Management, Schematics, Spreadsheets, Team Player, Technical/Engineering Design, Time Management, Validation Testing, Web Browsers, Word Processing
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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Katalyst Healthcares & Life Sciences