Edwards Lifesciences Veterans Jobs

Job Information

Edwards Lifesciences Staff Quality Engineer (Pilot - Catheter Center of Excellence) in Irvine, California

This exciting position on the Pilot team will provide quality engineering support for the creation of Edwards’ new center for Advanced Catheters. Qualified candidates should have experience in the design, development, and processing for catheters, steerable catheters, and/or sheaths. Specific experience with braiding, reflow, coiling, and bonding are preferred. Other skills are:

  • Initiative and leadership character

  • Effective communicator, both written and oral

  • Interested in working hard to build a fun, trusted, capable team

  • Medical device experience

  • Familiar with design controls and working in a regulated environment

Essential Job Functions:

  • Providing quality engineering support for R&D product development

  • Lead product transfers both into the group and out to production

  • Participate in the development of new manufacturing processes including data analysis and process analysis

  • Develop inspection methods and test method validations for new products

  • Implement quality system standards to meet as new products mature towards clinical/commercial application

  • Identify appropriate equipment and fixturing needed to develop new processes/inspections

  • Execute failure investigations (Root Cause Analysis and Corrective Action)

  • Create strategies for generating failure criteria

  • Disposition non-conforming materials

  • Performing Design of Experiments to resolve manufacturing issues

  • Optimize quality processes and procedures

  • Data collection and trending of key metrics during preliminary manufacturing orders

  • Address supplier quality issues

  • Validate new processes and equipment

  • Conduct risk analysis (Failure Mode Effects Analysis)

  • Review/approve Device Master Record changes

  • Transfer R&D prototype designs to full scale production

  • Develop quality controls for new manufacturing process

  • Lead feasibility studies

  • Work with vendor to establish design requirements and verify their processes

  • Work with suppliers to align dimensional stability and achieve stability metrics


Education and Minimum Requirements:

  • Bachelor’s Degree in Engineering or Scientific field and a minimum of 6 years (or Masters degree in Engineering with at least 5 years) of relevant medical device engineering experience

  • Experience in the design, development, and processing for catheters steerable catheters, and/or sheaths

Preferred Qualifications:

  • Experience in the design, development, and processing of extrusions

  • Specific experience with braiding, reflow, coiling, stent design, and bonding are preferred

  • Knowledge of Edwards Quality Management System

  • CQE & Six Sigma Black Belt preferred

Additional Talents and General Expectations:

  • Initiative and leadership character

  • Effective communicator, both written and oral

  • Interested in working hard to build a fun, trusted, capable team

  • Familiar with design controls and working in a regulated environment

  • Competent in the use of quality systems, statistical techniques, and risk management

  • Proficiency in the usage of relevant computer software

  • Excellent documentation and communication skills

  • Excellent interpersonal relationship skills including negotiating and relationship management skills

  • Advanced problem-solving, organizational, analytical and critical thinking skills

  • Extensive understanding of processes and equipment used in assigned work

  • Ability to influence others

  • Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

  • 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 frequent inter-organizational and outside customer contacts

  • Represents organization in providing solutions to difficult technical issues associated with specific projects

  • Experience with product design for manufacturing

  • Experience working in early R&D iterative design process

  • Experience developing quality strategies based on risk

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 15,000 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.