Sr. Quality Engineer - Implant Manufacturing

Irvine, CA

Miscellaneous Manufacturing

About the position

Imagine how your ideas and expertise can change a patient's life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You'll bring your passion for problem solving and partner with various teams to influence decision-making for a product's entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. 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.

Responsibilities

• 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.
• Identify and ensure the optimization of complex Manufacturing and/or R&D 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.
• Develop, update, and maintain technical content of risk management files.
• Collaborates with R&D, NPD, Pilot, Manufacturing, Operations, and personnel at other Edwards Manufacturing facilities to support Tissue & Solutions Operations projects and activities.
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
• 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.
• Other incidental duties assigned by Leadership.

Requirements

• Bachelor's Degree or equivalent in Engineering with 4 years in related industry experience OR Master's Degree in Engineering with 3 years in related industry experience.

Nice-to-haves

• Proven expertise in usage of MS Office Suite.
• ISO13485 Lead Auditor Certification.
• Medical device industry experience.
• Six Sigma Belt (Yellow / Green / Black) certification.
• 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.
• 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.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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.

Benefits

• Competitive salaries.
• Performance-based incentives.
• A wide variety of benefits programs to address the diverse individual needs of our employees and their families.