Engineer II, Quality

Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.

Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

This is an exciting opportunity within our Irvine Implant Manufacturing Plant supporting quality engineering for tissue and solutions used to build Surgical, THV and TMTT heart valves.  The Quality Engineer will be a key member of a cross-functional core team accountable for all aspects of the Tissue & Solutions operations value stream (safety, quality, delivery, compliance) by supporting tasks for sustaining and continuous improvement initiatives.  In this role, the engineer will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards’ systems’ procedures to optimize engineering activities from new product introduction, continuous improvement, global process transfers, line sustaining, validation activities and Manufacturing Execution System (MES) in our Implant Manufacturing group.

Applies 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.

Key Responsibilities:
• Investigate moderately 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.
• Optimize moderately 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

• Identify opportunities for re-design/design of basic equipment, tools, fixtures, MES, etc. to improve manufacturing processes, and reduce risk.
• Develop, update, and maintain technical content of risk management files.
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.

• Collaborates with R&D, NPD, Pilot, Manufacturing, Operations, and personnel at other Edwards Manufacturing facilities to support Tissue & Solutions Operations projects and activities.
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• Train, coach, and guide lower-level employees on routine procedures, root cause analysis, and quality system compliance.

• Perform other duties and responsibilities as assigned.

Education and Experience:
Bachelor's Degree or equivalent in in Engineering or related field, 2 years related industry experience Required or
Master's Degree or equivalent in in Engineering or related field, 1 year related industry or industry/education experience Required

Additional Skills:
• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills

• Proven expertise in usage of MS Office Suite

• Medical device industry experience is preferred
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills

• Strong understanding of applicable FDA regulations and ISO 13485 for medical device industry.
• 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