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:
As a member of the Quality Team, the Quality Engineer will review and monitor risk analyses, design verification/validation protocols and reports. Ensure test methodologies are technically sound and sufficient given level of risk assessed. Support regulatory requirements by participating in design reviews. Encourage continuous improvement in all documented procedures to help streamline production.
Key Responsibilities:
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Develop a thorough understanding of the entire product lifecycle for Endotronix product
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Provide quality engineering input to establishment of product specifications, quality plans, and manufacturing procedures which consider risk management
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Review and approve design verification and validation protocols and reports to ensure that test article selection, sampling rationales and test methodologies are technically sound and sufficient given level of risk and internal/external requirements.
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Review risk analyses and design and usability FMEAs for adherence to requirements
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Participate in design reviews to ensure customer and regulatory requirements have been properly translated into design inputs which are complete, unambiguous and do not conflict.
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Encourage continuous improvement in design control activities and proactive utilization of quality tools with design team.
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Support design for manufacturing in the design phase through design transfer to manufacturing, both internally and externally
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Support manufacturing process optimization to encourage reproducible quality outcomes
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Assist with management and monitoring of process control metrics in manufacturing environment.
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Develop sampling plans for quality assurance based on product risk and supplier performance
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Perform root cause analysis of field, incoming, and manufacturing issues and implement corrective actions.
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Apply learned techniques and contribute to analysis and investigation to solve problems
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Support suppliers and internal investigations on quality related issues and returned material analyses.
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Model a culture of quality within the company and guide employees in best quality practices.
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Build and enhance productive internal and external working relationships to resolve mutual problems by collaborating on procedures or transactions.
What you'll need (Required):
Bachelor's Degree in Engineering or related field, 4 years experience of related industry experience required OR
Master's Degree or equivalent in Engineering or related field, 3 years years experience related industry or industry/education experience required OR
Ph.D. or equivalent in Engineering or related field, 0 years years experience experience required
What else we look for (Preferred):
Desired:
• Experience in both design and manufacturing environments
• Experience in medical device industry, preferably with electromechanical devices and medical device software
• ASQ Certified Quality Engineer
• Technical writing skills, experience creating SOPs in a Quality Management System
• Experience with quality principles and tools
• Capability in application of statistical techniques and sampling plans
• Skills in root cause analysis and determination of appropriate corrective action
• Working knowledge of ISO13485 and ISO14971 requirements
• Strong organizational skills
• Proven ability to work independently and in a collaborative team environment
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 $106,000 to $149,000 (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.
Top Skills
What We Do
Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more.
Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today.
Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives.
Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life.
For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms
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