Edwards Lifesciences is growing and our  Manager, Software V&V Testing, 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 that develops 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:

• Lead the software testing efforts for all Cordella projects (medical software for an implantable class III device), following applicable software verification and validation V&V guidelines

• Manage a team of software test and automation engineers. Grow the team in size and skill

• Operate as a member of a Scrum Team, building and testing features in very short intervals (hours to days)

• Strict attention to detail.Educate the team on 21 CFR 820, EU MDR, and modern software testing techniques

• Point person for test related communications. Forecast testing timelines, liaise with Product teams, and manage test automation projects

• Produce “documentation audit packages” for software releases including test results and traceability

• Manage the Test Lab. Design and launch a reliability/performance test lab, with automated devices running various long term load tests.

• Launch a user-centered software validation program, to ensure the specific needs of our patients and clinicians (our users) are consistently met

• Lead and architect the direction and strategies of software testing across the organization, possibly providing centralized testing-as-a-service

• Drive and own improvement initiatives within software and QA

• Other Incidental duties

What you'll need (Required):

• Bachelor's degree in computer science or related field and 8 years' related experience required OR Master's degree or equivalent in computer science or related field and 6 years' related experience required

• Other: Certification (e.g. TOGAF, COBIT, ITIL, OCP, etc.) in related disciplines (e.g., programming, database development, project management) required

• Experience with Azure DevOps (ADO), Modern Requirements for ADO, Traceability and Test Plan management in ADO

• Professional Certifications or Personal Portfolio. Evidence of software testing craftsmanship, deep understanding, achievement, or technical creativity

What else we look for (Preferred):

• Demonstrate

• Ability to quickly synthesize information from a variety of sources, create a plan of action, and follow through

• Demonstrate solid performance in an architect role working with cross-functional teams on enterprise-level or complex/novel system implementations

• Relevant industry experience (e.g. medical device, pharmaceuticals, etc.) or in highly regulated environments

• Professional Scrum Master (PSMI) or experience on a Scrum team

• Advanced Testing related certifications or achievements

• Software development & coding experience

• Experience testing business IT systems (providing evidence for HITRUST, SOC2, and other IT-audit related projects)

• 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 (IL), the base pay range for this position is $118,000 to $167,000 (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.