The Senior Software Quality Assurance Engineer is a fantastic opportunity to join the Software Quality group at Edwards Lifesciences in applying knowledge of software quality engineering to assess risk and compliance issues. Edwards Lifesciences focuses on advancing technologies and improve the quality and efficiency of care. With over 40 years of technological advances, Edwards continues to evolve to less-invasive, and non-invasive devices; refine hemodynamic monitoring platforms; and provides evidence-based programs to enable proactive clinical decisions for surgical, anesthesia and critical care clinicians.

Key Responsibilities:
Lead cross functional discussions such as Software Change Control Meetings.
Lead as a Software Quality team member for SaMD and SiMD projects.
Lead and conduct Risk Management activities including authoring of Software Hazard Analysis.
Present risk documentation in design and technical review meetings as well as review and approve software and algorithm design control documentation.
Collaborate with stakeholders on new and legacy quality procedure improvements based on new regulations.
Develop and perform software documentation for product or non-product software validation deliverables utilizing engineering knowledge.
Support internal and external regulatory audits and inspections.
Train, coach, and guide lower-level employees on routine procedures and processes.
Other Incidental duties

Required Qualifications (Must Have):
Bachelor's Degree in Engineering, Computer Engineering, Computer Science, Scientific, or related fields with 4 years of relevant experience: OR Master's Degree in same disciplines with 3 years of relevant experience.
Demonstrated work experience with either Matlab or Python.
Previous experience with SDLC.
Experience working within Algorithm, Software, or V&V teams.

Preferred Qualifications (Desired):
Medical Device industry experience
Previous experience with Requirements Management, Risk Management, Test Management, Defect Management and Configuration Management is a plus.
Previous experience with SaMD.
Proven expertise in usage of MS Office Suite and PLM/ALM tools
Knowledge of IEC 62304, ISO 13485, ISO 14971, 21 CFR Part 11
Passionate about simple and clean code, unit testing and following standard coding practices.
Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
Substantial understanding and knowledge of principles, theories, and concepts relevant to Software Development Lifecycle related to Software Quality Engineering (e.g., CQE body of knowledge) for product and non-product software
Substantial knowledge of business acumen products and software technologies

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.

The base pay range for this position is $101,000 to $142,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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