Design Controls
Design Controls is a structured system that medical device companies use to make sure new products are developed safely and effectively. It's like a detailed roadmap that guides how medical devices are created, tested, and documented from initial idea to final product. This process is required by the FDA (Food and Drug Administration) for most medical devices. Think of it as a quality checklist that helps companies prove their devices are safe for patients and work as intended. Similar terms you might see include "Design Control Process," "Design Control System," or "Design Quality Management."
Examples in Resumes
Led implementation of Design Controls for Class II medical device development project
Managed Design Control documentation for regulatory submission to FDA
Created and maintained Design Controls procedures for R&D department
Typical job title: "Design Control Engineers"
Also try searching for:
Where to Find Design Control Engineers
Professional Organizations
Online Communities
Job Boards
Example Interview Questions
Senior Level Questions
Q: How would you implement Design Controls in a company that has never used them before?
Expected Answer: Should describe a systematic approach to implementing the process, including training staff, creating documentation systems, and ensuring FDA compliance. Should mention risk management and how to get buy-in from different departments.
Q: How do you handle design changes late in product development?
Expected Answer: Should explain change control process, impact assessment, documentation requirements, and how to maintain design controls while managing timeline pressures.
Mid Level Questions
Q: What are the key elements of Design Controls?
Expected Answer: Should mention design planning, inputs, outputs, verification, validation, reviews, transfer, and changes - explaining each in simple terms and how they connect.
Q: How do you ensure design inputs match user needs?
Expected Answer: Should discuss gathering user requirements, converting them to technical specifications, and verification methods to ensure the final design meets original needs.
Junior Level Questions
Q: What is the purpose of Design Controls?
Expected Answer: Should explain that Design Controls ensure medical devices are safe and effective through a documented development process that meets FDA requirements.
Q: What is the difference between design verification and validation?
Expected Answer: Should explain that verification confirms the design meets specifications, while validation ensures the device meets actual user needs and intended uses.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of FDA requirements
- Document control and management
- Basic quality system knowledge
- Assist with design reviews
Mid (2-5 years)
- Design Control procedure writing
- Risk management activities
- Design verification planning
- Change control management
Senior (5+ years)
- Design Control system implementation
- FDA audit management
- Cross-functional team leadership
- Design Control training development
Red Flags to Watch For
- No knowledge of FDA regulations
- Unfamiliarity with documentation requirements
- No experience with quality management systems
- Lack of understanding of risk management
- No experience with medical devices
Related Terms
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