Product Design Quality Engineer

Bothell, WA

Instant Apply

30+ days ago

Job Description

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.

Numbers & Facts

Location

Bothell, WA

Skills

Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Data Analysisunmatched
Design Verificationunmatched
Documentationunmatched
Electronic Engineeringunmatched
Identify Issuesunmatched
Manufacturing Requirementsunmatched
Mechanical Engineeringunmatched
Medical Equipmentunmatched
Process Developmentunmatched
Process Validationunmatched
Product Designunmatched
Product Lifecycleunmatched
Product Reviewsunmatched
Product Supportunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Research & Development (R&D)unmatched
Risk Analysisunmatched
Risk Managementunmatched
Root Cause Analysisunmatched
Safety/Work Safetyunmatched
Six Sigma Certificationunmatched
Six Sigma Green Beltunmatched
Statisticsunmatched
Surveillanceunmatched
Technical/Engineering Designunmatched
Validation Testingunmatched

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