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Test Method Validation

Karwell Technologies

Santa Clarita, CA

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JOB DETAILS
SKILLS
Analysis Skills, Bug Tracking/Defect Management, Change Control, Configuration Management, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Design Failure Mode and Effects Analysis (DFMEA), Design Verification, Documentation, Electrical Engineering, Electricity, FDA Requirements, Healthcare Quality, ISO (International Organization for Standardization), Maintain Compliance, Mechanical Engineering, Medical Equipment, Medical Products, Problem Solving Skills, Product Development, Product Lifecycle, Product Lifecycle Management, Product Support, Product Testing, Protocol Design, Quality Assurance, Quality Assurance Methodology, Quality Engineering, Quality Management, Quality System Requirements (QSR), Risk Management, Root Cause Analysis, Software Testing, Technical/Engineering Design, Test Design, Test Equipment, Validation Documentation, Validation Testing
LOCATION
Santa Clarita, CA
POSTED
30+ days ago
Job Summary:
  • We are seeking an Engineer to support product development and design verification activities for medical device programs.
  • The ideal candidate will have strong experience in Design Controls, Design Verification & Validation (DV&V), Risk Management, and Quality Engineering within a regulated medical device environment.
Roles & Responsibilities:
  • Review and support Design Verification deliverables, including protocols, reports, and summary reports.
  • Review and support Test Method Validation activities and test fixture design qualification.
  • Analyze regression impacts and ensure changes are properly assessed and justified.
  • Support Installation Qualification (IQ) activities for non-product software and test equipment.
  • Participate in risk management activities, including review and assessment of dFMEA for product subsystems.
  • Collaborate with cross-functional teams on defect tracking, issue resolution, test execution, and quality improvement initiatives.
  • Review build protocols, build reports, Device History Records (DHR), and configuration changes to assess impact on verification activities.
  • Review engineering design changes, including mechanical and electrical drawings.
  • Support the development and review of inspection plans for components and sub-assemblies.
  • Ensure compliance with Design Control processes and applicable quality system requirements.
  • Provide quality engineering support throughout the product development lifecycle.
Requirements:
  • Bachelor's degree in Engineering or a related technical discipline.
  • 5+ years of experience in Quality Engineering, Design Assurance, or Product Development Quality within the Medical Device industry.
  • Strong knowledge of Design Controls, Design Verification & Validation (DV&V), and Risk Management processes.
  • Experience reviewing Design Verification protocols, reports, and validation documentation.
  • Hands-on experience with dFMEA, defect management, and root cause analysis.
  • Familiarity with Device History Records (DHR), inspection plans, and configuration management.
  • Experience reviewing mechanical and electrical engineering documentation.
  • Knowledge of FDA Quality System Regulations, ISO 13485, and medical device development processes.
  • Strong analytical, documentation, communication, and problem-solving skills.
  • Experience with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Knowledge of CAPA, change control, and product lifecycle management processes.
  • Experience supporting complex medical device product development programs.

About the Company

K

Karwell Technologies

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