FMEA
FMEA (Failure Mode and Effects Analysis) is a planning tool that helps make products safer. Think of it like a very thorough "what could go wrong?" checklist that medical device companies use before making new products. Teams use FMEA to spot possible problems early, figure out how serious they could be, and prevent them from happening. It's similar to a risk assessment but more detailed and structured. You might see it written as "FMEA," "Design FMEA," or "Process FMEA" in resumes. Quality and engineering teams rely on FMEA because it helps meet FDA requirements and ensures medical devices are safe for patients.
Examples in Resumes
Led FMEA sessions for new insulin pump development project
Conducted Design FMEA and Process FMEA analyses for Class II medical devices
Improved product safety through implementation of FMEA recommendations
Typical job title: "Quality Engineers"
Also try searching for:
Where to Find Quality Engineers
Professional Organizations
Online Communities
Job Resources
Example Interview Questions
Senior Level Questions
Q: How would you implement an FMEA program in a medical device company that hasn't used it before?
Expected Answer: Should explain how they would train teams, set up documentation systems, and integrate FMEA into existing development processes. Should mention involving different departments and creating templates/standards.
Q: Tell me about a time when FMEA helped prevent a significant product issue.
Expected Answer: Should provide a specific example showing how they used FMEA to identify and prevent a potential problem, including what actions were taken and the outcome.
Mid Level Questions
Q: What's the difference between Design FMEA and Process FMEA?
Expected Answer: Should explain that Design FMEA looks at how the product might fail during use, while Process FMEA examines what could go wrong during manufacturing.
Q: How do you prioritize risks identified in an FMEA?
Expected Answer: Should discuss the RPN (Risk Priority Number) system and how severity, occurrence, and detection ratings help decide which risks need attention first.
Junior Level Questions
Q: What is FMEA and why is it important in medical device manufacturing?
Expected Answer: Should explain that FMEA is a systematic way to find potential problems before they happen, making products safer for patients and helping meet FDA requirements.
Q: What are the basic components of an FMEA form?
Expected Answer: Should mention failure modes, effects, causes, current controls, and risk ratings as key parts of the FMEA worksheet.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of FMEA process
- Ability to participate in FMEA meetings
- Understanding of medical device quality basics
- Familiarity with documentation requirements
Mid (2-5 years)
- Leading FMEA sessions
- Risk assessment and mitigation
- Understanding FDA requirements
- Experience with both Design and Process FMEA
Senior (5+ years)
- FMEA program development and management
- Training and mentoring teams
- Integration with risk management systems
- Complex medical device experience
Red Flags to Watch For
- No experience with medical device regulations
- Cannot explain basic risk assessment concepts
- No hands-on experience participating in FMEA sessions
- Lack of documentation experience
Related Terms
Need more hiring wisdom? Check these out...
Navigating Compliance: Structuring On-the-Job Training in Regulated Industries
Unlocking Team Potential: Personality Mapping for Dynamic Management
Global Compliance Checks: The Hidden Puzzle Pieces of Background Screening Revealed
