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.

How you will make an impact:

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.

Key Responsibilities:

• Investigate software-related complaints by analyzing system logs, user reports, and product performance data.

• Perform root cause analysis and collaborate with software development teams to identify corrective and preventive actions.

• Generate comprehensive failure investigation reports to support findings, root cause, regulatory requirements, and obtain the necessary approvals.

• Support risk management activities by assessing software-related failures and their potential impact on patient safety.

• Initiate discussions with management and QA when new failure mode(s) is(are) identified during failure analysis.

• Participate in Corrective Action/Preventive Action (CAPA) process as a CAPA owner or in a supporting role that includes the investigation of failures.

• Provide frequent verbal and written updates of work-in-progress for various meetings.

• Work closely with cross-functional teams to drive improvements in software quality, usability, and regulatory compliance.

• Assist in developing and maintaining complaint-handling procedures for software-related issues.

• Participate in software validation and verification activities to enhance product reliability.

• Ensure compliance with medical device regulations, such as FDA 21 CFR Part 820, ISO 13485, and IEC 62304.

• Contribute to post-market surveillance and trending analysis for software-related complaints.

What you'll need (Required):

Bachelor's Degree in in Engineering no experience Required or

Master's Degree or equivalent in Engineering or Scientific field no experience Required

Previous experience working with Software Preferred

What else we look for (Preferred):

• Experience with embedded systems and cloud-based medical software.

• Knowledge of software development life cycle (SDLC) and agile methodologies.

• Understanding of post-market surveillance requirements and complaint handling processes.

• Strong understanding of medical device regulations (FDA, ISO 13485, IEC 62304, and ISO 14971).

• Proficiency in software debugging, log analysis, and defect tracking tools.

Additional Skills:

• Familiarity with software validation and verification in regulated environments.

• Strong analytical, problem-solving, critical thinking, and communication skills.

• Ability to work independently and in cross-functional teams to resolve complex issues.

• Basic documentation, communication and interpersonal relationship skills

• Basic understanding of statistical techniques

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• Ability to manage competing priorities in a fast paced environment

• 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, the base pay range for this position is $67,000 to $96,000 (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.