Edwards Lifesciences

Principal Engineer, NPD Quality

Edwards Lifesciences

full-time

Posted on:

Location Type: Office

Location: Irvine • California • United States

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Salary

💰 $121,000 - $171,000 per year

Job Level

Lead

About the role

  • 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.

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.
  • 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.
Benefits
  • Competitive salaries
  • Performance-based incentives
  • Wide variety of benefits programs to address individual needs
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
quality engineering principlesdesign controlrisk managementusability testingSix SigmaLeanmanufacturing processestest method validationdata analysisprotocol writing
Soft Skills
leadershipcommunicationinterpersonal skillsnegotiationrelationship managementproblem-solvingorganizational skillsanalytical skillscritical thinkingattention to detail