Principal Engineer, Reliability & Failure Investigation

Location: This position will be onsite or hybrid but offers flexibility in work location and can be based at either our Irvine, CA corporate campus or Draper, UT facility.

Innovation starts from the heart. Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. 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. The Principal Engineer, Reliability & Failure Investigation position is a unique career opportunity that could be your next step towards an exciting future.

The Principal Engineer, Reliability & Failure Investigation role will be a member or our Worldwide Engineering organization and focused on leading highly complex failure investigations and deploying innovative problem-solving methods to uncover drivers of failure, determine root causes, and recommend corrective actions of product issues. This role will have the opportunity to partner with teams across Edwards (all business units, plants, and products) to ensure our life-saving devices meet the highest standards of reliability and safety.

How You’ll Make an Impact:

• Plan and direct complex reliability engineering evaluations of product and process designs to identify critical-to-performance elements for testing in view of relevant physical stressors.  Identify risks and develop mitigation strategies in collaboration with cross functional stakeholders.
• Plan, lead and direct failure analysis investigations related to Field Corrective Actions, complaints, qualification failures, and manufacturing process control excursions and non-conformances to establish root cause and implement corrective actions to establish product and process reliability.
• Lead, propose, and implement technological capabilities related to Reliability and Failure Analysis Engineering.
• Champions the reliability program throughout the organization by incorporating latest reliability engineering methodologies into the product development process and coaching/influencing engineering teams in the field of reliability and failure analysis
• Drives design for reliability techniques including root cause analysis, FMEAs, reliability hazard analysis, accelerated age testing, design margin analysis,  and application of statistical tools for reliability evaluation (e.g., DOE, regression, , etc.)
• Translates relevant data/information into broadly understandable risks and provides means for trade-off discussions
• Provides expert guidance on requirements development, test planning, test execution, fixturing, automation, and test results evaluation
• Responsible for mentoring others within the team and throughout the organization to ensure successful adoption and execution of reliability engineering and failure analysis strategy
• Drafts, routes, reviews, and approves test method procedures, validation protocols, design for reliability plans, and technical summaries
• Perform other duties and responsibilities as assigned

What You’ll Need (Required Qualifications):

• Bachelor's degree in engineering or scientific disciplines with at least six (6) years of related experience; OR Master's degree in engineering or scientific disciplines with at least five (5) years of related experience
• Experience with reliability and/or failure analysis engineering
• Highly regulated industry experience

What Else We Look For (Preferred Qualifications):

• Engineering degree
• Six Sigma Black Belt or Master Black Belt certification
• Experience in forensic failure analysis techniques and root cause identification (e.g. SEM fractography)
• Proficiency in statistical tools and utilizing complex investigative techniques (e.g. DMAIC, test method development, regression analysis, DOE, and COV)
• Strong knowledge of root cause analysis tools (e.g., Fault Tree, 5-Whys, Fishbone)
• Experience using engineering first principle thinking and design methodology
• Experience in the medical device or regulated industry (FDA, ISO 13485)
• Familiarity with reliability modeling, Weibull analysis, or accelerated life testing
• Proven successful project management leadership skills and leading cross-functional investigations & teams
• Experience with tools like Minitab, JMP, or similar statistical software
• Knowledge of design controls for Class II & III medical devices, including familiarity with implantable devices and delivery systems
• Excellent communication, interpersonal, and collaborative skills
• Experience designing and executing HALT, ALT, and stress testing to analyze reliability of product design
• Experience communicating technical concepts and investigations to a wide variety of audiences, including technical and non-technical senior leadership

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 $118,000 to $167,000 (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.