2nd Shift Senior Engineer, Manufacturing QA

Edwards Lifesciences • Irvine, CA

1d • Onsite

About The Position

Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world. The Senior Engineer 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. The standard hours for this role are on-site Monday-Friday 2-11pm in Irvine, CA.

Requirements

• Bachelor's Degree in Engineering or related field, 4 years related industry experience required or Master's Degree or equivalent in Engineering or related field, 3 years related industry or industry/education experience required or Ph.D. or equivalent in Engineering or related field, 0 years experience required
• Previous experience working with lab/industrial equipment required
• Proven expertise in usage of MS Office Suite
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.
• Working knowledge and understanding of statistical techniques.
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
• Strong problem-solving, organizational, analytical, attention to detail 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.
• 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.

Nice To Haves

• CAD experience highly preferred.

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.
• 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 junior employees on routine procedures.

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree