This role involves leading the setting of quality and reliability targets for IGT Systems medical software to ensure outstanding product reliability
Job Summary
This role involves leading the setting of quality and reliability targets for IGT Systems medical software to ensure outstanding product reliability.
The engineer is responsible for validating key design inputs including safety, security, privacy, and sustainability while facilitating failure mode analysis.
Candidates must have extensive experience in medical device regulations such as ISO 13485, EU MDR, and IEC 62304 to guide audits and inspections.
Matching Summary
This role involves leading the setting of quality and reliability targets for IGT Systems medical software to ensure outstanding product reliability.
Skills & Requirements
Must-have
Software Quality Engineering in Medical Industry
Reliability Engineering and Risk Management
Design Controls and FMEA Facilitation
Verification Validation and Usability Testing
Statistical Data Analysis and Reliability Growth
DHF DMR Document Review Experience
Knowledge of ISO 13485 IEC 62304 Standards
Nice-to-have
Self-motivated mindset prioritizing excellence
Experience with Software Testing
Ability to inspire cross-functional teams
Strong interpersonal communication skills
High-tech R&D environment experience
Key Requirements
Bachelor's degree with 12 years or Master's with 10+ years experience
Experience in Software Engineering or Quality Engineering within medical industry
Understanding of global medical device regulations and standards