Staff Quality Engineer, New Product Development-014119
The NPD Staff Quality Engineer will be working in a dynamic and fast paced environment. The individual is responsible for ensuring execution to Edwards’ Product Development Process. As part of a cross functional team that includes: Sustaining R&D, Operations, Regulatory Affairs, Marketing and other functions, , this person will be integral in driving technical decisions, leading or supporting product failure investigations, and is accountable for project schedule associated with disposable and electronic products.Throughout the development phases, the QE responsibility will focus on design control, design verification & validation (including first on human and clinical trials), failure analysis & investigation, risk management, specification development, device reliability, and inspection/test methodologies. During the design transfer phases, the QE responsibility will focus on process development & characterization, process validation, product inspection and test method validation, and transfer to Commercial Operations facilities.
This position will provide opportunities for advancement within our growing organization. We are looking for an individual who has strong technical and communication skills, initiative, accountability and ability to work with cross functional teams.
Apply knowledge of quality engineering principles and methods to ensure compliance to standards and regulatory requirements.
Review and approval of proposed design changes, partner with R&D in the design of safe and effective devices
Ensure that design control activities are executed per Edwards’ Product Development Process
Lead comprehensive root cause investigations for component and device failures and non-conformances by utilizing Six Sigma techniques and applicable root cause analysis tools.
Lead and / or support the activities associated with any non-conforming components or product including but not limited to, Product disposition, Product Risk Assessment, NCRs, Stop Shipments, RMC, Quality Board, FCA
Provide technical quality support for design qualifications, design transfer, activities for Regulatory submissions, development and implementation of design control documents, presentations for design reviews, and approval of product/process changes
Provide technical quality support for equipment and process validations (IQ/OQ/PQ)
May train, mentor, and coach junior level Quality Engineers
Required Education & Skills:
A Bachelor of Science degree in Mechanical, Biomedical, Chemical, or equivalent engineering degree is required
Minimum of 6 years’ experience in Quality or Manufacturing is required
Knowledge of equipment/process qualification and design verification in the medical device industry or other regulated industries is required
Must be able to work effectively and collaboratively within cross functional teams
Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel
Excellent interpersonal relationship skills including negotiating and relationship management skills
Robust statistical skills and analytical thinking. CQE and/or Six Sigma Black Belt training and applicable experience is preferred
Quality engineering experience in new product development is preferred
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 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
USA-USA-California - Irvine