Edwards Lifesciences Senior Software Quality Engineer in Salt Lake City, Utah
Senior Software Quality Engineer
The Senior Software Quality Engineer will be an essential support team member for multiple production lines and new product development areas at the Draper location. The candidate will be the validation process owner of Edwards’ manufacturing, testing, and data systems. We are looking for an individual who has strong technical and communication skills, thinks critically, takes initiative, and demonstrates ability to work with cross-functional teams.
Responsibilities for this position include:
Work in close partnership with IT, manufacturing, facilities, and quality to validate new equipment, equipment modifications, and updates to data systems
Work with individual teams to define strategy for validating new custom and COTS software platforms
Perform day to day software quality activities to ensure that equipment and data systems demonstrate that the software meets specification requirements and works as intended per user needs and systems requirements.
Assess risk management of software systems and own hazard analyses
Support engineer’s tasks self-contained validations within equipment qualifications
Support audit activities to explain validation rationales
WORK EXPERIENCE REQUIREMENTS
Technical and professional competencies for this position are as follows:
Must have a Bachelor’s degree in science or engineering or equivalent work experience of three (3) to five (5) years.
Experience in software development, software quality and/or software V&V is preferred
Ability to read and interpret various code languages is preferred
Experience in supporting regulatory body agency audits (FDA) is preferred
Knowledge and experience with quality systems and processes is preferred
Manufacturing experience is preferred
Highly detailed, interpersonal skills, and ability to defend quality assurance is required
Excellent written and verbal communication skills
Ability to manage competing priorities in a fast-paced environment
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.