Edwards Lifesciences Quality Engineer II - Transcatheter Mitral & Tricuspid Therapies in Irvine, California
**RELOCATION NOT BUDGETED (Irvine, CA-based position)
This is a unique opportunity to play a critical role in the growth of new cutting-edge heart valve therapies for Transcatheter Mitral & Tricuspid Valve repair and replacement. The Quality Engineer II will apply knowledge of technical 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
Investigate complex product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
Participate in and own escalation tasks and activities, including Project Risk Assessments (PRAs) and Corrective/Preventive action(s) (CAPAs) as determination by investigation.
Identify and report key complaint metrics per device category and collaborate with applicable R&D, clinical development, and manufacturing engineering teams to investigate and resolve device related issues.
Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.
Update and maintain technical content of risk management files.
Support development of moderately complex experiments and tests (including writing and executing protocols) to investigate issues and improve products and manufacturing methods based on engineering principles; analyze results, make recommendations, and develop reports
Other incidental duties assigned by Leadership
Education and Minimum Requirements:
Bachelor's degree in Engineering or Scientific field and 2 years relevant industry experience required, OR
Master's Degree or equivalent and internship, senior projects, or thesis in Engineering or Scientific field including relevant industry experience or combined industry/education experience required
- New Product Development (NPD), design assurance, and design verification experience for class III medical device
Additional Talents and General Expectations:
Proven expertise in usage of MS Office Suite including MS Project
Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
Strong problem-solving, organizational, analytical and critical thinking skills
Good leadership skills and ability to influence change
Experience with medical devices and knowledge of applicable FDA regulations for medical device industry
Strict attention to detail
Complaints investigation experience and/or hands-on experience with device investigations
Basic understanding of statistical techniques
Ability to interact professionally with all organizational levels and manage competing priorities in a fast-paced environment
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on projects
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.