Principal Engineer, Quality

Edwards Lifesciences · Cartago

Imagine how your ideas and expertise can change a patient’s life. 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.

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.
How you'll make an impact:

Lead in the identification and ensure the optimization of 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 more complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.
Drive the development and manage the execution of 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 collaborate with team members to drive project completion
Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations and develop reports
Train, coach, and guide lower level employees on more complex procedures
Develop technical content of risk management files
Manage Supplier Quality Activities as needed
Other incidental duties

What you'll need (Required):
Bachelor's degree in engineering or Scientific field, 6 years of experience minimum of experience, including either industry or industry/education or
Master's Degree or equivalent in Engineering or Scientific field, 5 years of experience minimum of experience, including either industry or industry/education or
Ph.D. or equivalent in Engineering or Scientific field, 2 years of experience minimum of experience, including either industry or industry/education
What else we look for (Preferred):

Proven expertise in usage of MS Office Suite
Ability to read and interpret drawings
Proven expertise in statistical techniques
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
Ability to translate technical information to all levels of the organizations
Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)
Knowledge of Six Sigma concepts with ability to apply to work product
Knowledge of Quality Engineering concepts with ability to apply to work product
Advanced problem-solving, organizational, analytical and critical thinking skills
Extensive understanding of processes and equipment used in assigned work
Strong leadership skills and ability to influence change
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Work is performed independently while exercising considerable latitude in making significant decisions
Set policies and standards that are followed by others
Guides others in resolving basic issues in specialized area based on existing solutions and procedures
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
Develops technical solutions to complex problems which require the regular use of creativity
Uses best practices and knowledge of internal or external business issues to improve products/services or processes
Typically resolves complex problems or problems where precedent may not exist
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

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