Principal Engineer, NPD-Quality

Edwards Lifesciences•Irvine, CA

6d•$121,000 - $171,000•Onsite

About The Position

The Principal Quality Engineer, NPD will support Edwards Lifesciences’ Transcatheter Heart Valve business in Irvine, California. The role provides Quality Engineering support and technical leadership for new product development, helping ensure successful design and development of new products in a fast-paced, growing environment. The engineer collaborates across functions and applies design control and risk management principles from concept through product launch, including design verification, validation, and development of design and manufacturing specifications. The position also oversees the work and talent development of assigned direct reports and ensures compliance with applicable regulations, policies, and procedures. Domestic and international travel of up to 10% may be required.

Requirements

Bachelor’s degree in Engineering or a scientific field and at least six years of related experience; or a master’s degree in Engineering or a scientific field and at least five years of related experience; or a PhD in Engineering or a scientific field and at least two years of related experience.
Knowledge of and experience with design control and risk management/usability engineering in the medical device industry or other regulated industries.
Working knowledge of domestic and international medical-device regulatory requirements, including FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366, and other applicable requirements.
Ability to work in a team environment, including interdepartmental teams, and represent the organization with key stakeholders on projects.

Nice To Haves

Current or prior experience in the medical device industry.
Quality Engineering experience in New Product Development.
Knowledge and experience in Design Assurance, including Design Controls, Design Verification and Validation, Test Method Development, and Process Validation.
New Product Development experience from initial concept to commercialization; Class III experience preferred.
ASQ Certified Quality Engineer (CQE), Quality System Lead Auditor, Certified Six Sigma Black Belt (CSSBB), or related quality/regulatory certification.
Strong documentation, communication, and interpersonal skills, including negotiation and relationship management skills.
Ability to prioritize, plan, and evaluate deliverables against established strategic goals.
Ability to interact professionally with all organizational levels.
Ability to manage competing priorities in a fast-paced environment.
Experience with Risk Management and Design Control.
Working knowledge of domestic and international medical-device regulatory requirements.
Expertise using MS Office Suite, including MS Project.
Basic understanding of statistical techniques.
Strong problem-solving, organizational, analytical, and critical-thinking skills.
People leadership experience, including direct-line reporting responsibilities.

Responsibilities

Provide technical leadership for new product development projects, applying design control and risk management principles from concept through launch.
Collaborate with cross-functional stakeholders and peers to align on goals and drive actions that meet commitments.
Lead development and updates of risk management files for new products.
Lead test method development and validation activities for new designs.
Lead failure investigations for product failures in design testing and clinical use.
Lead development and implementation of inspection and testing mechanisms for components, sub-assemblies, and final assemblies used in product design and manufacturing.
Develop technical solutions to complex problems and recommend and implement corrective actions using creativity, statistical techniques, and reliability engineering.
Collaborate with manufacturing and operations teams to support successful transfer and launch of robust products.
Manage or oversee the work of assigned direct reports within the function.
Develop talent plans aligned with individual and departmental growth strategies.
Ensure compliance with Federal, State, local, and company regulations, policies, and procedures.
Perform other incidental duties assigned by management.
Travel up to 10% domestically and internationally.