KH
Test Method Validation
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
4 months ago
- Risk Management
- Configuration Management
- CAPA
4 months ago
- 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.
- 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.
Test Method Validation · Katalyst Healthcares & Life Sciences