Principal Engineer, NPD Quality

Edwards Lifesciences

Irvine, CA

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JOB DETAILS

SALARY

$121,000–$171,000 Per Year

SKILLS

Analysis Skills, Automation Systems, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Cardiovascular Disease, Cleanroom, Clinical Practices/Protocols, Coaching, Communication Skills, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Customer Relations, Data Analysis, Design Verification, Detail Oriented, Documentation, Environmental Health, External Audit, Healthcare Providers, Internal Audit, Interpersonal Skills, Leadership, Lean Six Sigma, Maintain Compliance, Manufacturing, Manufacturing/Industrial Processes, Materials Testing, Medical Equipment, Microsoft Office, Negotiation Skills, Patient Care, Problem Solving Skills, Process Development, Product Development, Product Lifecycle, Quality Assurance Methodology, Quality Engineering, Quality Management, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Relationship Management, Reporting Skills, Requirements Management, Research & Development (R&D), Risk, Risk Management, Safety/Work Safety, Sales Management, Technical Writing, Test Plan/Schedule, Training/Teaching, Usability Engineering, Vaccination, Validation Testing, Vendor/Supplier Sourcing

LOCATION

Irvine, CA

POSTED

30+ days ago

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 Principal Engineer, NPD Quality, position is a unique career opportunity that could be your next step toward an exciting future.

Imagine how your ideas and expertise can change a patient’s life. Our New Product Development Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross‑functionally with Manufacturing, Clinical, Regulatory, and R&D teams, delivering thoughtful solutions to complex challenges while expanding your knowledge of the medical device industry.

You Will Make an Impact By:

+ Applying knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards systems/procedures for new product development.

+ Providing leadership and oversight for devices, systems, or projects to develop, update, and maintain design control throughout the product development lifecycle; supporting the creation and refinement of design requirement documentation.

+ Developing, updating, and maintaining the technical content of risk management and usability files.

+ Leading the identification, development, and optimization of complex Manufacturing and/or R&D processes using engineering methodologies (e.g., Six Sigma, Lean) to support DFM and continuous improvement initiatives.

+ Identifying opportunities and implementing solutions for the design or redesign of complex equipment, new technologies (including automation and software), tools, fixtures, and related components to enhance manufacturing processes and/or test methods and reduce overall process and product risk.

+ Driving the development and managing the execution of complex experiments and tests, including writing and executing protocols, to create, validate, and improve products; evaluating source materials and suppliers; and establishing robust processes and test methods grounded in engineering principles.

+ Ensuring completion of usability studies, design verification and validation, and process/test method validations, including analyzing data and generating comprehensive reports.

+ Collaborating with cross‑functional partners to support project success and ensure on‑time completion of deliverables.

+ Leading investigations into complex product quality and compliance issues (e.g., pre‑commercial complaints, CAPA, non‑conformances, audit observations, PRAs) during new product development; analyzing results, making recommendations, and generating reports.

+ Serving as a subject matter expert during internal and external audits for products and/or processes; supporting regulatory submissions and addressing regulatory inquiries.

+ Training, coaching, and guiding junior engineers and technicians on advanced procedures; overseeing Quality support tasks; providing instruction on test execution; and coordinating work as needed.

+ Performing other incidental duties as assigned.

What You’ll Need (Required):

+ Bachelor’s degree in Engineering or a Scientific field and 6 years of related experience, including either industry or industry/education; OR

+ Master’s degree or equivalent in Engineering or a Scientific field and 5 years of related experience, including either industry or industry/education; OR

+ Ph.D. or equivalent in Engineering or a Scientific field and 2 years of related experience, including either industry or industry/education.

What Else We Look For (Preferred):

+ Proven expertise using the MS Office Suite; CAD experience preferred.

+ Excellent documentation, communication, and interpersonal relationship skills, including negotiation and relationship management.

+ Ability to translate complex technical information to all levels of the organization.

+ Extensive knowledge of engineering principles, theories, and concepts relevant to the role.

+ Advanced problem‑solving, organizational, analytical, and critical‑thinking skills.

+ Strong understanding of manufacturing processes and equipment used in assigned work.

+ Demonstrated leadership skills with the ability to influence change.

+ Knowledge of and adherence to Edwards EHS and Quality guidelines, particularly those related to cleanroom medical device manufacturing.

+ High attention to detail in all aspects of work.

+ Ability to interact professionally with all organizational levels.

+ Ability to manage competing priorities in a fast‑paced environment.

+ Ability to work effectively in team settings, including frequent cross‑functional and external customer interactions.

+ Ability to represent the organization by providing solutions to complex technical issues associated with specific projects.

+ Adherence to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and the ability to take appropriate measures to prevent injury, protect the environment, and prevent pollution within their span of influence.

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 $121,000 - $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.

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

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

About the Company

Edwards Lifesciences

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