*This role is located on-site in Naperville, Illinois.

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

The Failure Analysis Technician plays a critical role in the complaint investigation process by performing hands-on testing of returned medical devices and day-to-day support of the testing lab. This position supports the identification of product issues through meticulous testing, documentation, and collaboration with engineering, quality, and regulatory teams. The ideal candidate has strong technical aptitude, excellent documentation skills, and a passion for continuous improvement. Additionally, the technician will be responsible for lab organization and the intake, tracking, and proper disposition of returned products.

How you'll make an impact:

• Performing detailed functional testing and evaluation of returned devices following standard operating procedures and test protocols.

• Working closely with engineers to replicate reported issues and contribute to root cause analysis.

• Accurately documenting test results, observations, and findings in accordance with Good Documentation Practices (GDP).

• Coordinating intake of returned products, including logging returns into tracking systems, assigning identifiers, and preparing devices for testing.

•  Maintaining accurate inventory of returned devices and associated components throughout the complaint investigation lifecycle.

• Managing the final disposition of returned products post-investigation in compliance with quality and regulatory requirements.

• Ensuring the lab is clean, organized, and compliant with safety and regulatory standards.

• Setting up and operating test fixtures, tools, and diagnostic equipment such as multimeters, oscilloscopes, and data loggers.

• Performing routine maintenance, calibration, and setup of test equipment and lab tools.

• Assisting in the preparation of complaint investigation summaries and technical reports.

• Maintaining compliance with FDA regulations, ISO 13485 standards, and internal quality

policies.
• Other incidental duties as assigned by leadership.

What you'll need (Required):
• Associate's Degree or equivalent in or technical degree/certificate with 2 years previous experience in R&D Lab and/or medical device experience Required or
• 4 years related experience Required
• Medical device industry experience is highly preferred.

What else we look for (Preferred):

• Proficiency using basic diagnostic equipment and tools.

• Strong analytical and troubleshooting skills.

•Familiarity with complaint handling systems and quality management software

• Good computer skills including MS Office Suite.
• Good communication and interpersonal relationship skills.
• Able to read, write, comprehend, and speak English.
• General knowledge and understanding of Edwards’ policies and procedures.
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to device manufacturing.
• Attention to detail.
• Ability to work in a team environment, including contacts across the organization, and may include external contacts.
• 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.

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 Illinois (IL), the base pay range for this position is $52,000 to $73,000 (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.