ISO 14971
ISO 14971 is an important safety standard that medical device companies must follow. It provides a systematic way to identify and reduce potential risks in medical devices before they reach patients. Think of it as a detailed safety checklist and process that helps companies make sure their medical products won't harm users. When someone lists ISO 14971 on their resume, it means they understand how to evaluate and manage safety risks in medical device development. This is similar to how car manufacturers test their vehicles for safety, but specifically for medical equipment and devices.
Examples in Resumes
Led risk management team implementing ISO 14971 processes for new medical devices
Conducted ISO 14971 risk assessments on Class II medical devices
Trained manufacturing team on ISO 14971 risk management procedures
Typical job title: "Risk Management Engineers"
Also try searching for:
Where to Find Risk Management Engineers
Professional Organizations
Online Communities
Job Boards
Example Interview Questions
Senior Level Questions
Q: How would you implement an ISO 14971 risk management process in a company that has never had one?
Expected Answer: Should explain steps like creating documentation systems, training staff, establishing review processes, and integrating risk management into product development. Should mention importance of management buy-in and cultural change.
Q: How do you handle post-market surveillance in relation to ISO 14971?
Expected Answer: Should discuss monitoring device performance after release, gathering customer feedback, tracking complaints, and updating risk assessments based on real-world data.
Mid Level Questions
Q: What are the main components of a risk management file?
Expected Answer: Should mention risk analysis, risk evaluation, risk control measures, and documentation of decisions. Should explain how these pieces work together.
Q: How do you determine if a risk is acceptable under ISO 14971?
Expected Answer: Should explain the balance between medical benefits and potential risks, using data to support decisions, and following company risk acceptance criteria.
Junior Level Questions
Q: What is the purpose of ISO 14971?
Expected Answer: Should explain that it's a standard for managing safety risks in medical devices throughout their lifecycle, from design to disposal.
Q: What is a risk assessment and why is it important?
Expected Answer: Should explain that it's a process of identifying potential problems that could harm patients or users, and figuring out how to prevent these problems.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of risk assessment process
- Familiar with medical device documentation
- Can perform basic risk analysis
- Understands safety requirements
Mid (2-5 years)
- Complete risk management file creation
- Risk control measure implementation
- Team training and coordination
- Quality system integration
Senior (5+ years)
- Program development and oversight
- Cross-functional team leadership
- Risk management strategy creation
- Regulatory compliance management
Red Flags to Watch For
- No knowledge of basic risk management terms
- Unfamiliar with medical device regulations
- No experience with documentation systems
- Can't explain risk assessment basics
Related Terms
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