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Edwards Lifesciences Principal Engineer, NPD - Design Assurance in Irvine, California

Principal Engineer, New Product Development - Design Assurance

Summary:

The Principal Quality Engineer (QE) will provide support for transcatheter mitral and tricuspid development projects focusing on risk management, test method development, inspection methodologies, and design transfer. This includes close coordination with manufacturing sites for test or clinical builds as well as lab activities for design verification testing with R&D. The QE will work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.

Key Responsibilities:

  • Apply expert knowledge of quality engineering principles and methods to ensure compliance with Edwards Quality System and Regulatory requirements. Focus on design control, design verification/validation, FMEA/risk management, specification development, statistical reliability, critical to quality/process control, acceptance sampling, and inspection/test methodologies

  • Subject matter expert (SME) for responsible product/project within the overall manufacturing and processing of delivery systems, including leveraging of key knowledge of quality engineering principles

  • Critical review and approval of design changes; partner with R&D in the design of safe and effective devices; partner with Manufacturing Engineering to develop critical manufacturing processes and provide technical quality engineering support for pilot production of test or clinical devices

  • Identify opportunities for re-design/design of more complex equipment, tools, fixtures, etc. to improve manufacturing and inspection process, and reduce risk

  • Drive the development and manage the execution of highly complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports and lead team members to drive project completion

  • Develop technical content of risk management files.

  • Develop training and documentation materials for production (e.g., inspection documents) to enable the seamless knowledge transfer of project and manufacturing processes from NPD to Operations

  • Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work

  • Train, coach, and guide lower level employees on routine procedures.

Education and Experience Requirements:

  • Bachelor's Degree + minimum of 8 years OR Master's Degree + minimum of 7 years OR Doctorate in Engineering or Scientific field + minimum of 4 years’ experience, including either industry or industry/education required

  • Previous experience working in new product development and demonstrated understanding of design control in early and later stages preferred

Additional Skills:

  • Ability to identify and implement quality system documentation components, including quality policies and procedures to support the project and guide the cross functional team

  • Strong knowledge in design control, product and process development, FMEA, control methods such as quality control plan development, critical control point identification, and work instruction development and validation. Experience with process or product transfer to alternate manufacturing sites preferred.

  • Ability to interpret the concepts of producer and consumer risk and related terms, including operating characteristics (OC) curves, acceptable quality limit (AQL), lot tolerance percent defective (LTPD), average outgoing quality (AOQ), and average outgoing quality limit (AOQL)

  • Ability to identify, interpret, and apply ANSI/ASQ Z1.4 And Z1.9 standards for attributes and variables sampling. Identify and distinguish between single, double, multiple, sequential, and continuous sampling methods.

  • Knowledge in selecting and describing appropriate uses of inspection tools

  • Demonstrates troubleshooting skills and capability in evaluating process changes and/or non-conformances for risk, development of technical justifications, and assessments for PRA and/or FCA. Also includes demonstrated experience owning and managing a CAPA through its full lifecycle.

  • Experience working with R&D to affect design for manufacturing, mistake-proofing and robust design transfer to manufacturing

  • CQE (Certified Quality Engineer) and Black Belt preferred

  • Proven expertise in usage of MS Office Suite; CAD experience preferred

  • Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills

  • Working knowledge and understanding of statistical techniques

  • Previous experience working with lab/industrial equipment required

  • 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 and high standards

  • 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 inter-departmental teams and key contact representing the organization on contracts or projects

  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

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.

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