Senior Engineer, Quality

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences, a leading global structural heart innovation company, seeks a Senior Engineer, Quality in Irvine, CA. This role supports valve operations, applies quality principles across development and manufacturing, and drives continuous improvement while ensuring regulatory compliance.

The position emphasizes problem solving, cross-functional collaboration, and mentoring of technicians within a fast-paced, safety-focused environment. Expect travel up to 5%.

Qualifications

• Bachelor's Degree in Engineering or related field with 4 years' related industry experience OR Master's Degree or equivalent in Engineering or related field with 3 years related industry or industry/education experience.
• Strong documentation, communication, and interpersonal skills.
• Substantial understanding of the principles, theories, and concepts relevant to Quality Engineering.
• Knowledge of and adherence to Quality systems.
• Working knowledge of statistical techniques.

Responsibilities

• Support 1st shift of Irvine Implant Manufacturing's valve operations across RESILIA processing, sterilization, and packaging.
• Apply quality engineering principles to keep systems and procedures compliant with regulatory requirements while optimizing product development, device manufacturing, and distribution.
• Investigate complex product quality and compliance issues (CAPA, non-conformances, audit observations) across all production processes prior to final product release.
• Analyze results, make recommendations, and develop reports.
• Optimize complex manufacturing processes using Six Sigma and Lean to drive design for manufacturing and continuous process improvement.
• Identify opportunities to design or re-design equipment, tools, and fixtures that improve manufacturing processes and reduce risk.
• Develop, update, and maintain the technical content of risk management files.
• Create training and documentation materials for production (e.g., work instructions) to enable knowledge transfer of project and manufacturing processes.
• Coordinate technician work, supervise tasks, and mentor lower-level employees on routine procedures.
• Adhere to all company rules and requirements and enforce safety and environmental protections.

Skills

Quality Engineering

Quality Systems

Statistical Techniques

Documentation & Communication

Leadership Skills

MS Office

Team Collaboration

Problem-Solving

Education

Bachelor's Degree in Engineering

Master's Degree in Engineering

Tools

MS Office Suite

Job description

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs.Our Senior Engineer, Quality position is a unique career opportunity that could be your next step towards an exciting future. 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.

How you will make an impact:

• Support 1st shift of Irvine Implant Manufacturing's valve operations across RESILIA processing, sterilization, and packaging.
• Apply quality engineering principles to keep our systems and procedures compliant with regulatory requirements while optimizing product development, device manufacturing, and distribution.
• Investigate complex product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) across all production processes prior to final product release.
• Analyze results, make recommendations, and develop reports.
• Optimize complex manufacturing processes using quality engineering methods (e.g., Six Sigma and Lean) to drive design for manufacturing and continuous process improvement.
• Identify opportunities to design or re‑design equipment, tools, and fixtures that improve manufacturing processes and reduce risk.
• Develop, update, and maintain the technical content of risk management files.
• Create training and documentation materials for production (e.g., work instructions) to enable seamless knowledge transfer of project and manufacturing processes.
• Assign support tasks and provide direction to technicians on conducting tests; train, coach, and provide feedback; and coordinate technician work.
• Train, coach, and guide lower-level employees on routine procedures.
• 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.

What you’ll need (Required):

• Bachelor's Degree in Engineering or related field with 4 years' related industry experience OR Master's Degree or equivalent in Engineering or related field with 3 years related industry or industry/education experience.

What else we look for (Preferred):

• Substantial understanding of the principles, theories, and concepts relevant to Quality Engineering.
• Knowledge of and adherence to Quality systems.
• Working knowledge of statistical techniques.
• Strong documentation, communication, and interpersonal skills, including negotiation and relationship management.
• Prior experience working with laboratory or industrial equipment.
• Strong problem-solving, organizational, analytical, and critical‑thinking skills.
• Substantial understanding of the processes and equipment used in assigned work.
• S
  olid leadership skills and the ability to influence change.
• Proven proficiency with MS Office Suite.
• Strict attention to detail.
• Ability to manage competing priorities in a fast‑paced environment.
• Ability to interact professionally across all organizational levels.
• Ability to work effectively in a team environment, including inter‑departmental teams, and serve as a key contact representing the organization on contracts or projects.
• Ability to interact with senior internal and external personnel on significant matters, often requiring coordination between organizations.

Travel for this position can be up to 5%.

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, the base pay range for this position is $108,000 to $153,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world‑class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient‑focused culture to deliver life‑changing innovations to those who need them most.