Product Design Quality Engineer

Bothell, WA, US • Posted 20 hours ago • Updated 9 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Product Design
  • Regulatory Compliance
  • Data Analysis
  • Quality Assurance
  • Documentation
  • Management
  • Risk Assessment
  • Surveillance
  • Research and Development
  • Manufacturing
  • Mechanical Engineering
  • Electronic Engineering
  • Science
  • Six Sigma
  • Design Controls
  • Verification And Validation
  • DV
  • Risk Management
  • Corrective And Preventive Action
  • Root Cause Analysis
  • Medical Devices

Summary

Summary :
This is a Product Design Quality / Design Quality Engineering role in the medical device / regulated product domain. The engineer will support the complete product lifecycle, especially Design Control, Design Verification & Validation (V&V), Risk Management, CAPA, RCA, Process Validation, PMS, and regulatory compliance.

Roles & Responsibilities :
  • Manage the Design Control process from design inputs through verification, validation, and design transfer.
  • Develop and execute process validation strategies using statistical/data-analysis methods.
  • Prepare and maintain Quality Plans and other quality engineering documentation.
  • Perform Design Verification (DV) and Design Validation (PV) planning and support execution.
  • Review product/system designs for quality, reliability, safety, performance, and manufacturability.
  • Perform Root Cause Analysis (RCA) for product and quality issues.
  • Manage CAPA activities, including investigation, corrective action, and effectiveness checks.
  • Support Risk Management/Risk Assessment throughout the product lifecycle.
  • Use Post-Market Surveillance (PMS) data to identify product quality issues and improvement opportunities.
  • Work with R&D, Manufacturing, Regulatory, Quality, and external stakeholders.
Experience & Experience:
  • Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent.
  • Six Sigma Green Belt certification is preferred.
  • Master's degree: No prior experience is specified as mandatory.
  • Preferred experience includes Design Control, Design Verification & Validation (DV/V), Process Validation, Risk Management, CAPA, RCA, PMS, and medical-device/regulatory quality.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: d1cc09f6c771a29f7ce5165997b354dd
  • Posted 20 hours ago
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