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:
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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
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Manage a team of software test and automation engineers. Grow the team in size and skill
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Operate as a member of a Scrum Team, building and testing features in very short intervals (hours to days)
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Strict attention to detail. Educate the team on 21 CFR 820, EU MDR, and modern software testing techniques
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Point person for test related communications. Forecast testing timelines, liaise with Product teams, and manage test automation projects
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Produce “documentation audit packages” for software releases including test results and traceability
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Manage the Test Lab. Design and launch a reliability/performance test lab, with automated devices running various long term load tests.
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Launch a user-centered software validation program, to ensure the specific needs of our patients and clinicians (our users) are consistently met
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Lead and architect the direction and strategies of software testing across the organization, possibly providing centralized testing-as-a-service
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Drive and own improvement initiatives within software and QA
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Other Incidental duties
What you'll need (Required):
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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
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Other: Certification (e.g. TOGAF, COBIT, ITIL, OCP, etc.) in related disciplines (e.g., programming, database development, project management) required
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Experience with Azure DevOps (ADO), Modern Requirements for ADO, Traceability and Test Plan management in ADO
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Professional Certifications or Personal Portfolio. Evidence of software testing craftsmanship, deep understanding, achievement, or technical creativity
What else we look for (Preferred):
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Ability to quickly synthesize information from a variety of sources, create a plan of action, and follow through
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Demonstrate solid performance in an architect role working with cross-functional teams on enterprise-level or complex/novel system implementations
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Relevant industry experience (e.g. medical device, pharmaceuticals, etc.) or in highly regulated environments
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Professional Scrum Master (PSMI) or experience on a Scrum team
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Advanced Testing related certifications or achievements
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Software development & coding experience
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Experience testing business IT systems (providing evidence for HITRUST, SOC2, and other IT-audit related projects)
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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 $136,000 to $192,000 (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
