Edwards Lifesciences Quality Engineer II - Post-market Surveillance (Surgical Structural Heart) in Irvine, California
We have a great opportunity for a Quality Engineer in the Surgical Structural Heart post-market surveillance team.
This individual will perform device complaint evaluations and apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
Perform testing, assess results, and document routine complaint product device evaluations in support of complaint investigations including dimensional and functional analysis.
Perform analysis in No Product Return Evaluations by utilizing multiple data inputs including technical review of device history records (DHR review), in support of complaint investigations
Collaborate with other engineers on non-routine testing in support of failure investigation and root cause analysis.
Plan, organize, and prioritize complaint investigation activities based on complaint closure and reportability timelines.
Generate weekly complaint reports to provide data for weekly production meetings.
Organize and track complaint product returns and investigational follow-up inquiries related to product investigations in partnership with complaint handlers.
Perform queries on historical complaint data to support complaint investigations.
Collaborate with other Engineers in preliminary complaint product evaluations to determine standard or non-routine device failures. Document, communicate, and escalate results, as applicable.
Education and Minimum Requirements:
Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering or related engineering field with 2+ years of relevant industry experience (cardiovascular, endovascular, or other surgical device), or other relevant life sciences industry; OR Master's Degree or equivalent and internship, senior projects, or thesis in Engineering field including relevant life sciences industry experience or combined industry/education experience
Complaints investigations experience within an FDA-regulated life science industry
Additional Talents and General Expectations:
Experience conducting root cause investigation and prepare reports, for negative trends of process or product failures or critical characteristics not being met.
Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment required
Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
Solid problem-solving, organizational, analytical and critical thinking skills
Solid understanding of processes and equipment used in assigned work
Knowledge of and adherence to Quality systems
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
Ability to build productive internal/external working relationships
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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.