Senior Quality Engineer, Reader, Endotronix

Edwards Lifesciences is growing and our

Senior Quality Engineer, Reader, Endotronix

position is a unique career opportunity that could be your next step towards an exciting future. This role will sit within the Endotronix team, who develop implantable heart monitoring technology. Endotronix was acquired by Edwards in July 2024, and will support our future work with heart failure management solutions to address large unmet structural heart patient needs and support sustainable long-term growth.

For more details on the acquisition, please visit:

https://www.edwards.com/newsroom/news/2024-07-24-edwards-lifesciences-expands-structural-heart-port

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:

Develop a thorough understanding of the entire product lifecycle for Endotronix product

Provide quality engineering input to establishment of product specifications, quality plans, and manufacturing procedures which consider risk management

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.

Review risk analyses and design and usability FMEAs for adherence to requirements

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.

Encourage continuous improvement in design control activities and proactive utilization of quality tools with design team.

Support design for manufacturing in the design phase through design transfer to manufacturing, both internally and externally

Support manufacturing process optimization to encourage reproducible quality outcomes

Assist with management and monitoring of process control metrics in manufacturing environment.

Develop sampling plans for quality assurance based on product risk and supplier performance

Perform root cause analysis of field, incoming, and manufacturing issues and implement corrective actions.

Apply learned techniques and contribute to analysis and investigation to solve problems

Support suppliers and internal investigations on quality related issues and returned material analyses.

Model a culture of quality within the company and guide employees in best quality practices.

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.