Edwards Lifesciences Senior Quality Engineer (Implant Manufacturing - 2nd Shift) in Irvine, California
*2nd shift position
**Currently unable to consider those requiring relocation
The Senior Quality Engineer role provides support and oversight on commercial class III, implantable devices for Edwards' comprehensive portfolio of treatments for structural heart disease within the Surgical, Transcatheter Heart Valves (THV), and Tricuspid & Mitral Transcatheter Therapies (TMTT) business units. This individual will 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.
Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
Review product submitted to Material Review Board to disposition in accordance with product specifications and inspection criteria
Conduct audits and walkthroughs of manufacturing areas to ensure compliance to procedures and requirements
Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
Identify and ensure the optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
Train, coach, and guide lower level employees on routine procedures
Update and maintain technical content of risk management files
Other incidental duties assigned by leadership
Education and Minimum Requirements:
Bachelor's Degree or equivalent in in Engineering or related field, 4 years' experience relevant industry experience OR
Master's Degree or equivalent in in Engineering or related field, 3 years' experience relevant industry or industry/education experience
Process quality engineering experience for a class III medical device manufacturer
Additional Talents and General Expectations:
Proven expertise in usage of MS Office Suite; CAD experience preferred
Strong documentation, communication and interpersonal relationship skills, including relationship management skills
Working knowledge and understanding of statistical techniques
Previous experience working with manufacturing processes
Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
Strong problem-solving, organizational, analytical and critical thinking skills
Substantial understanding of processes and equipment used in assigned work
Good leadership skills and ability to influence change
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 independently and collaboratively in a small team environment, including inter-departmental teams
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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.