Test Method Validation

Katalyst CRO; Santa Clarita (CA); On-site; USD 90,000 - 150,000; Full time

Job summary

Katalyst CRO in California is seeking an Engineer to support medical device product development and design verification activities. The ideal candidate will bring strong experience in Design Controls, DV&V, Risk Management, and Quality Engineering within a regulated medical device environment.

Responsibilities include reviewing and supporting DV&V deliverables, test method validation, risk assessments, IQ/OQ/PQ, DHRs, and accompanying documentation; collaborating with cross-functional teams and

Qualifications

• 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.

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.

Skills

Design Controls

DV&V

Risk Management

Quality Engineering

Documentation

Education

Bachelor's degree in Engineering

Job description

• 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.
• 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.

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.

Education & Experience:

• 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.