Vacancy expired!
- Ensure products consistently meet customer requirements and industry regulations
- Perform feasibility evaluations
- Perform failure root cause analysis (FMEA, FTA, 5 why, Fishbone)
- Perform traceability analysis
- Support FDA and other regulatory submission and audits to maintain regulatory compliance
- Transfer designs to manufacturing
- Ability to code in python
- Experience with CAD designs (preferably solidworks)
- Experience interfacing with electromechanical systems
- Experience debugging mechanical systems
- Familiar with FDA design controls (ISO 13485, IEC 62304, IEC 61010, and ISO 14971)
- Experience with Risk management activities (ISO 14971)
- Experience with systems verification and validation
- Experience working within Med Device industry (IVD industry a plus)
- Experience with reliability design a plus
- Electrical engineering background a plus (knowledge of PCB design, layout etc.)
- Experience with Design Controls around user needs, intended use, system requirements, design and traceability
- Bachelors or Masters Degree in related field
Vacancy expired!