Principal Quality Engineer, NPD — Medical Devices

Edwards Lifesciences Gruppe; Redhill (MD); On-site; USD 121,000 - 171,000; Full time

Job summary

Edwards Lifesciences is seeking a Principal Quality Engineer, NPD for the Transcatheter Heart Valve (THV) team in Irvine, CA. The role provides technical leadership in new product development, applying design control and risk management to drive from concept through launch.

You will collaborate with cross-functional teams, develop and update risk management files, lead test method development and validation, and investigate product failures in design testing and clinical use.

Qualifications

• Bachelor’s Degree in Engineering or Scientific field with years of related experience or higher degrees with required experience
• Experience with design control and risk management/usability engineering in medical devices or regulated industries
• Knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366 and related regulatory requirements

Responsibilities

• Provide technical leadership for new product development projects through design control, risk management, verification and validation
• Collaborate with cross-functional stakeholders to align goals and drive actions
• Lead risk management file updates for new products
• Lead test method development and validation for new designs
• Lead failure investigations in design testing and clinical use
• Develop inspection and testing strategies for components and assemblies
• Develop technical solutions using statistics and reliability methods
• Support transfer and launch of robust products with manufacturing
• Mentor team members and develop talent
• Travel up to 10% domestically and internationally

Skills

Design controls

Risk management

Usability engineering

Cross-functional collaboration

MS Office

MS Project

Education

Bachelor’s Degree in Engineering or Scientific field

Master’s Degree in Engineering or Scientific field

PhD in Engineering or Scientific field

Tools

MS Office Suite

MS Project

Job description

Edwards Lifesciences is seeking a Principal Quality Engineer, NPD for the Transcatheter Heart Valve (THV) team in Irvine, CA. The role provides technical leadership in new product development, applying design control and risk management to drive from concept through launch.

You will collaborate with cross-functional teams, develop and update risk management files, lead test method development and validation, and investigate product failures in design testing and clinical use.