Engineer II, NPD- Quality

Edwards Lifesciences; Irvine, Northern (CA, KY); Hybrid; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences seeks a Quality Engineer in New Product Development to support risk management and ensure regulatory compliance across the product lifecycle. You will collaborate with engineers, clinicians, and cross-functional teams to drive problem solving and improve manufacturing processes for life‑saving therapies.

The role emphasizes creating test protocols, maintaining quality documentation, and addressing CAPAs, all while aligning with Edwards’ safety and integrity standards.

Qualifications

• Strong documentation, communication and interpersonal skills including negotiation and relationship management.
• Solid problem-solving, analytical and critical thinking abilities.
• Familiarity with quality systems, regulatory requirements, and risk management.

Responsibilities

• Develop moderately complex experiments and tests, write protocols, and analyze results to improve products and manufacturing processes.
• Develop, update, and maintain risk management files content.
• Investigate manufacturing quality and compliance issues (CAPA, non-conformances, audits) prior to final release.
• Optimize manufacturing processes using Six Sigma and LEAN methods for continuous improvement.
• Develop training and documentation for production to transfer knowledge.

Skills

Documentation

Communication

Problem-solving

Interpersonal skills

Negotiation

Education

Bachelor's degree in Engineering or Science

Master's degree or equivalent

Tools

Quality systems

Lab/industrial equipment

Job description

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision‑making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open‑heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Do you thrive on solving difficult problems and turning innovative ideas into life‑changing therapies? Our New Product Development Quality team works at the intersection of innovation, risk management, and patient impact. Partnering with engineers, clinicians, and cross‑functional teams, you’ll help shape the development of breakthrough medical technologies by solving complex challenges, reducing risk, and influencing critical decisions throughout the product development process.

In this role, you’ll apply quality engineering expertise to enable innovation while ensuring compliance with regulatory requirements and Edwards’ quality systems. Every project presents new opportunities to tackle technical challenges, collaborate with diverse teams, and help bring safe, effective, and reliable therapies to patients around the world.

How you will make an impact:

• Develop moderately complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports.
• Develop, update, and maintain technical content of risk management files.
• Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non‑conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
• Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re‑design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• Other incidental duties assigned by Leadership.

What you’ll need (Required Qualifications):

• Bachelor's Degree in Engineering or Scientific field, 2 years’ experience related work experience or
• Master's Degree or equivalent in and internship, senior projects or thesis in Engineering or Scientific field including either industry or industry/education

What else we look for (Preferred Qualifications):

• CQE (Certified Quality Engineer), preferred
• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid problem‑solving, organizational, analytical and critical thinking skills
• Solid understanding of processes and equipment used in assigned work
• Knowledge of and adherence to Quality systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
• Ability to build productive internal/external working relationships
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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 $87,000 to $123,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accep