Medical Device Design Quality Engineer — DV​/V, CAPA & Risk

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.

• 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.