Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Engineer, Software Quality position is a unique career opportunity that could be your next step towards an exciting future. Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. **How you will make an impact:** + Developing complex software documentation for non-product software validation deliverables utilizing engineering knowledge. + Adopting the CSA approach to projects. + Validating ERP and computer systems (i.e. PLM, LIMS, Quality systems, MES/SCADA). + Developing Installation / Operational Qualification protocols (IQ,OQ). + Participating and authoring user requirements documents. + Collaborating with stakeholders on the Code Review process for custom manufacturing applications + Training, coaching, and guiding lower-level employees on routine procedures and processes. **What you’ll need (Required):** + A Bachelor's degree in Engineering or Scientific field with 4 years of previously related industry experience OR Master’s degree in Engineering or Scientific field with 3 years of previously related industry experience Required. **What else we look for (Preferred):** + Knowledge of the CSA approach. + Experience with validating ERP and computer systems (i.e. PLM, LIMS, Quality systems, MES/SCADA) + Understanding of testing automation + Ability to develop and drive a methodology for CSV + Proven expertise in usage of MS Office Suite; CAD experience preferred + Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills + Working knowledge and understanding of statistical techniques + Previous experience with Risk Management required + 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 + Strong problem-solving, organizational, analytical and critical thinking skills + Substantial understanding of processes and equipment used in assigned work + Good leadership skills and ability to influence change + Knowledge of and adherence to related procedures (e.g., Cybersecurity procedures related to IT systems, manufacturing equipment or product software). + Strict attention to detail + Ability to interact professionally with all organizational levels + Ability to manage competing priorities in a fast-paced 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 California, 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.