Product Design Quality Engineer

Katalyst Healthcares & Life Sciences; Bothell (WA); On-site; USD 90,000 - 130,000; Full time

Job summary

Fives DyAG Corp. in Bothell, WA seeks a Product Design Quality / Design Quality Engineering professional to support the full lifecycle of medical devices, focusing on Design Control, DV/V, risk management, CAPA, RCA, and PMS.

You will collaborate with R&D, Manufacturing, Regulatory and Quality to ensure regulatory compliance and robust product quality across design transfer, process validation, and post-market surveillance.

Qualifications

• Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent.
• Six Sigma Green Belt preferred.
• Experience in Design Control, DV/V, Process Validation, Risk Management, CAPA, RCA, PMS in medical-device/regulatory quality.

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.

Skills

Quality engineering

Design controls

Risk management

Root cause analysis

Data analysis

Statistical methods

Education

Bachelor's or Master's degree in Mechanical/Electronics Engineering or Science

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.