Edwards Lifesciences is growing and our Engineer II, Software Quality, 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:

You will apply your knowledge of software quality engineering to assess risk and compliance issues. The Software Quality Engineer understands software quality development and implementation, software inspection, testing, verification, and validation, and implements software development and maintenance processes and methods. This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout the product lifecycle. Develop and conduct training of company personnel for the software development and validation program. Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes.

Key Responsibilities:

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

Provide quality engineering input to establishment of product specifications, quality plans, and software development/deployment procedures which consider risk management

Review and approval of 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 software development and test process optimization to encourage reproducible quality outcomes

Perform root cause analysis of field and internal issues and implement corrective actions.

Support suppliers and internal investigations on quality related issues.

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

Design, implement, debug, and document test cases and scripts to ensure that software meets the business needs, while in compliance with applicable regulations and processes.

Update and optimize quality assurance software development procedures.

Collaborate with other team members and product owners, both inside and outside of the team.

Support the design and execution of tests using automated test tools, as well as manual test development process, for the verification of software requirements.

Support test infrastructure set up and test tool development, such as test tools, Hardware/Firmware simulators and emulators.

Assist development team on debugging and solving issues discovered during test.

Review project/product documentation

Work closely with developers and Systems Engineers to understand the specifics of the Application, Mobile device & operating platform on which the Application would run and due considerations

Work across teams to ensure all deployment processes are documented, repeatable, and stable

Support automated software builds, tests, and deployments

Complete tasks and projects in a timely manner to meet software release schedule

Support and review software validation protocols traceable to system/software requirements.

Assist in the completion and maintenance of risk analysis, focused on software related risks.

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving issues.

Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.

Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

What you'll need (Required):

Bachelor's Degree in in Engineering or Scientific field including either industry or industry/education, minimum of 2 years years experience Required or

Master's Degree or equivalent in in Engineering or Scientific field including either industry or industry/education Required or

internship, senior projects, or thesis Required

Previous experience working with Software VNV (Verifications and Validation) Preferred

What else we look for (Preferred):

Detailed knowledge of FDA, 21CFR820, IEC 62304 and ISO 13485.

Prior medical device experience preferred. ASQ CSQE certification desired.

Proficiency with IEC 62304 standards and FDA software development and pre/post market cybersecurity guidance documents

Proficiency with software validation tools for product software/firmware, production software/firmware, OTS software, QMS software and spreadsheets.

Proficiency with waterfall software development, incremental/iterative and Agile software development life cycles

Proficiency with software configuration change management and bidirectional traceability

Advanced computer skills, including statistical/data analysis and report writing.

Ability to work in a highly matrixed and geographically diverse business environment.

Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

Builds productive internal and external working relationships to resolve mutual challenges

Exercises judgment within defined procedures and practices to determine appropriate actions.

Determines a course of action based on guidelines and modifies processes and methods as required

Ability to leverage and/or engage others to accomplish projects.

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Strong organizational and follow-up skills, as well as attention to detail.

For Illinois (IL), 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.