Product Design Quality Engineer Katalyst Healthcares & Life Sciences - 4.0 Bothell, WA Job Details Contract 1 day ago Qualifications Incident investigation techniques for hazard identification Bachelor's degree in mechanical engineering Statistics Quality records maintenance Defect resolution root cause analysis Six Sigma Green Belt Medical device testing Quality control statistical data analysis Preventive action implementation Regulatory compliance Electronics Engineering Mechanical Engineering Reliability analysis Corrective and preventive actions (CAPA) No experience needed Master's degree Collaboration with product development teams Bachelor's degree in engineering Production validation processes Quality risk management Master's degree in mechanical engineering Compliance documentation Collaboration with manufacturing teams Design controls Biomedical regulatory compliance Product quality failure Entry level Test Planning (Quality assurance practices) Under 1 year Product lifecycle management

Full 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.