Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
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.  You’ll apply your knowledge to support various elements of the Quality System such as Complaint investigations, Non-Conformance Investigations, and general failure analysis.

How you will make an impact: 
• Perform complex failure analysis of devices/components returned with alleged malfunctions or associated with internal nonconformances.
• Acquire, analyze, and interpret information from data logs and various applications as part of root cause analysis.
• Utilize failure analysis laboratory equipment, such as: optical digital microscopes, probes, custom electrical test software, data log applications, and other test equipment and fixtures in support of failure analysis.
• Maintain and calibrate specialized lab equipment for accurate analysis.
• Participate and/or conduct validation or qualifications tests of new or existing failure analysis equipment in accordance with internal procedures.
• Collaborate with engineering, product development, complaint management, supplier quality and manufacturing functions to ensure returned product investigations fully address reported events.
• Develop and implement methods and procedures to assist in product analysis investigations.
• Determine potential interaction between reported event and all Endotronix system components.
• Generate comprehensive failure investigation reports to support findings, root cause, regulatory requirements, and obtain the necessary approvals.
• Create and develop engineering projects for improvements of analysis/investigation process, methodologies, and procedures.
• Provide direction for failure analysis technicians to ensure that field returns are evaluated appropriately to deliver clear investigation results and potential root causes for identified failures.
• 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.
• Other incidental duties assigned by Leadership

What you'll need (Required):

• Bachelor's Degree in Engineering or Scientific field, 2 years’ experience related work experience OR
• Master's Degree or equivalent and internship, senior projects or thesis in Engineering OR Scientific field including either industry or industry/education
• Experience with quality principles and tools.
• Skills in root cause analysis and determination of appropriate corrective action.
• Working knowledge of ISO 13485 requirements.
• Technical writing skills, experience creating SOPs/WIs in a Quality Management System

What else we look for (Preferred):

• Experience in the medical device industry, preferably with electromechanical devices and medical device software.
• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Basic understanding of statistical techniques
• Ability to work in a team environment, manage multi-tasking, and discipline in completing tasks on schedule.
• Previous experience working with lab/industrial equipment required
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid problem-solving, organizational, analytical and critical thinking skills
• Solid understanding of processes and equipment used in assigned work
• Knowledge of and adherence to Quality systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
• Ability to build productive internal/external working relationships
• 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 $85,000 to $120,000 (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.