Design Verification
Design Verification is a required quality control process in medical device manufacturing that ensures a product is built correctly according to its design specifications. It's like a thorough checklist system that confirms all the requirements set during the design phase are met in the final product. This process is essential because medical devices directly impact patient safety. Companies must do this to comply with FDA regulations and similar rules in other countries. You might also see it called "DV," "Design V&V" (Verification and Validation), or "Product Verification."
Examples in Resumes
Led Design Verification testing for a new cardiac monitoring device
Conducted Design Verification and DV protocols for Class II medical devices
Managed Design V&V activities for respiratory equipment development
Typical job title: "Design Verification Engineers"
Also try searching for:
Where to Find Design Verification Engineers
Professional Organizations
Online Communities
Job Boards
Example Interview Questions
Senior Level Questions
Q: How would you develop a design verification strategy for a new medical device?
Expected Answer: A strong answer should mention risk assessment, creating test protocols based on design requirements, considering FDA guidelines, planning resources and timeline, and ensuring traceability of all tests to design requirements.
Q: How do you handle design verification failures?
Expected Answer: Should discuss investigation process, documentation requirements, working with design teams to resolve issues, impact assessment on project timeline, and ensuring proper communication with stakeholders.
Mid Level Questions
Q: What's the difference between design verification and design validation?
Expected Answer: Should explain that verification ensures the product meets design specifications (building it right), while validation ensures the product meets user needs (building the right thing).
Q: How do you document design verification testing?
Expected Answer: Should mention test protocols, acceptance criteria, data collection methods, proper documentation of results, and the importance of maintaining records for regulatory compliance.
Junior Level Questions
Q: What is the purpose of design verification?
Expected Answer: Should explain that it's to ensure the product meets all specified requirements and design specifications before moving to production.
Q: What documents are typically involved in design verification?
Expected Answer: Should mention test protocols, requirements documentation, test results, reports, and any deviation or failure documentation.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of medical device regulations
- Test protocol execution
- Documentation practice
- Basic quality system knowledge
Mid (2-5 years)
- Test protocol development
- Risk analysis participation
- Project coordination
- Technical writing skills
Senior (5+ years)
- Verification strategy development
- Team leadership
- Risk management expertise
- Regulatory compliance oversight
Red Flags to Watch For
- No knowledge of FDA quality system regulations
- Lack of documentation experience
- Poor understanding of medical device development process
- No experience with test protocol development or execution
- Unfamiliarity with risk management principles
Related Terms
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