Principal Engineer, NPD Quality

Edwards Lifesciences•Irvine, CA

1d•$121,000 - $171,000

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.