Lead Quality Engineer, NPD — MedTech THV

Edwards Lifesciences; Irvine, Northern (CA, KY); Hybrid; USD 121,000 - 171,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA seeks a Principal Quality Engineer, NPD to provide technical leadership in new product development for THV devices. You will apply design controls, risk management and validation from concept through product launch, collaborating with cross-functional teams.

The role requires expertise in medical device design controls, regulatory standards, and strong leadership within a fast-paced environment.

Qualifications

• Bachelor’s Degree in Engineering or Scientific field with 6+ years related experience; OR a Master’s with 5+ years; OR a PhD with 2+ years.
• Knowledge of design control and risk management/usability in medical devices or regulated industries.
• Familiar with FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366 and other regulatory requirements.

Responsibilities

• Provide technical leadership for successful NPD projects applying design control and risk management from concept to launch.
• Collaborate with cross-functional stakeholders to align goals and drive actions to meet commitments.
• Lead development and updates to risk management files for new products.
• Lead test method development and validation activities for new designs.
• Lead failure investigations and corrective actions for product failures.
• Oversee transfer and launch of robust products with manufacturing and operations.

Skills

Technical leadership

Design controls

Risk management

NPD experience

Statistical methods

Validation

Leadership

Cross-functional

Education

Bachelor's degree in Engineering or Science

Master's degree in Engineering or Science

PhD in Engineering or Science

Tools

MS Office

MS Project

Job description

Edwards Lifesciences in Irvine, CA seeks a Principal Quality Engineer, NPD to provide technical leadership in new product development for THV devices. You will apply design controls, risk management and validation from concept through product launch, collaborating with cross-functional teams.

The role requires expertise in medical device design controls, regulatory standards, and strong leadership within a fast-paced environment.