Principal Engineer, Quality

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

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
This Principal Quality Engineer, NPD will be part of Edwards Lifesciences growing Transcatheter Heart Valve (THV) business in Irvine, CA. We are looking for a strong engineer with solid technical expertise, who enjoys working in a fast paced and rapidly growing environment where taking initiative and collaborating cross-functionally are critical for success. The engineer will have a variety of responsibilities in New Product Development providing Quality Engineering support and leadership to ensure the successful design and development of new products.

How you will make an impact:

• Providing technical leadership for successful new product development projects by applying design control and risk management principles to positively influence new product development efforts from concept through product launch including design verification, validation, and design and manufacturing specification development.
• Partner and collaborate with cross-functional stakeholders and peers on new product development teams to align on goals and drive actions to meet commitments.
• Lead development and drive updates to 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 mechanism for components, sub-assemblies, and final assemblies used in new product design and manufacturing
• Develop technical solutions to complex problems, recommend and implement corrective actions, using creativity, statistical techniques, and reliability engineering
• Collaborate with manufacturing and operations team to ensure successful transfer and launch of robust products.
• Managing/overseeing the work of an assigned team of direct reports within own function.
• Developing a robust talent development plan in alignment with functional growth strategies of the individual and the department.
• Ensure compliance with all Federal, State, local and company regulations, policies and procedures.
• Performs other incidental duties as assigned by management
• Ability to travel up to 10% domestically and internationally

What you’ll need (Required):

• Bachelor’s Degree in Engineering or Scientific field with a minimum of six (6) years related experience required; OR a Master’s Degree in Engineering or Scientific field with a minimum of five (5) years related experience; OR a PhD in Engineering or Scientific field with a minimum of two (2) year related experience.
• Knowledge of and experience with design control, risk management/usability engineering within medical device industry or other regulated industries
• Working knowledge of the Domestic and International regulatory requirements of Medical Device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366; and other applicable regulatory requirements)

What else we look for (Preferred):

• Current or prior experience within Medical Device industry
• Must be able to work in a team environment, including inter-departmental teams and key stakeholders representing the organization on projects
• Quality Engineering experience in New Product Development
• Knowledge and experience within Design Assurance, including Design Controls, Design Verification & Validation, Test Method Development, and Process Validation
• New Product Development experience from initial concept to commercialization (Class III preferred).
• ASQ Certified Quality Engineer (CQE), Quality System Lead Auditor, Certified Six Sigma Black Belt (CSSBB), or related quality/regulatory certifications a plus
• Strong documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills
• Ability to prioritize, plan, and evaluate deliverables to 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 the Domestic and International regulatory requirements of Medical Device regulations
• Proven expertise in usage of MS Office Suite including MS Project
• Basic understanding of statistical techniques
• Strong problem-solving, organizational, analytical and critical thinking skills
• Experience in people leadership including direct line reporting responsibilities

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $121,000 to $171,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.