Edwards Lifesciences Software Quality Senior Engineer, Automated Mfg and Product Sustaining Software in Irvine, California
The Senior Software Quality Engineer will be a essential member of the Software Quality organization. The candidate will report into the Software Quality Manager responsible for Automated Manufacturing and NPD Sustaining SWQE functions. The candidate will execute SWQE activities to provide quality products and processes related to custom software used in manufacturing and product software in a medical device (SiMD) after commercial release. This position will provide opportunities for advancement within our growing organization. We are looking for an ambitious candidate with a strong technical background, excellent communication skills (comfortable presenting to all levels of seniority), and the ability to build trusting relationships within the organization.
Responsibilities for success in this position include:
Executing Software Maintenance Plans for SiMD in compliance with IEC62304 and Edwards procedures.
Providing Product Risk Analysis (PRA) support for commercially release SiMD
Assisting in improving and creating new processes and procedures related to custom manufacturing software used to automate manufacturing processes based on latest industry trends; including IOT, AI and data-driven technologies (Industry 4.0).
Working in close partnership with Global Supply Chain Validation, Automation and IT Teams to ensure custom software used in manufacturing remains in a validated state and supports business needs.
Responsible for traceability of requirements and testing activities based on risk analysis.
Assisting in software supplier audits.
Supporting and providing strategic guidance to remote manufacturing plants utilizing custom software
Effectively manage priorities, multiple projects and ability to communicate at all levels of personnel.
Work Experience Requirements
Technical and professional competencies for this position are as follows:
Must have a Bachelor’s degree in Sciences or Engineering or equivalent work experience of five (5) years.
Requires a minimum of three (3) years in a regulated industry.
Requires a minimum of three (3) years in manufacturing equipment / test tool validations utilizing custom software.
Excellent written and verbal communication skills required.
Familiarity with software automation or custom software used in manufacturing is required.
Highly detailed, interpersonal skills and ability to defend software quality assurance is required.
Solution orientated, generates multiple innovative solutions.
Knowledge and experience in Quality Systems Risk Management (ISO14971) and GAMP solutions and processes is preferred.
Experience in Manufacturing or Product SiMD Software Quality, and/or V&V is preferred.
Experience in implementing tool solutions with IT or external suppliers is preferred.
Experience in verification activities for Equipment, Process, Software, and Test Method Validations preferred.
Experience in automation framework, programming, databases and scripting a plus.
Some travel required
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.