Edwards Lifesciences is looking to improve patient lives by optimizing product development, manufacturing, and distribution through the application of quality engineering principles and methods.
Requirements
- Extrusion Experience
- Balloon Development Experience
- Proven expertise in usage of MS Office Suite
- Ability to read and interpret drawings
- Proven expertise in statistical techniques
- 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
Responsibilities
- Lead identification, development, and optimization of complex Manufacturing processes using engineering methods (e.g., Six Sigma and Lean manufacturing tools) for design for manufacturing and continuous process improvement initiatives.
- Identify opportunities & implement solutions for re-design/design of complex equipment, new technologies (including automation and software), tools, fixtures, etc. to improve manufacturing processes and reduce overall process/product risk profile.
- 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 establish robust manufacturing processes/methods based on engineering principles; ensure completion of comprehensive process validations (IQ/OQ/PQ), including analyzing results and developing reports; collaborate with cross-functional team members to facilitate project success and on-time completion
- Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
- Develop technical content of risk management files
- Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., SCAR, CAPA, non-conformances, audit observations) for all supplier production processes and based on engineering principles; analyze results, make recommendations and develop reports
- Train, coach, and guide lower level employees on more complex procedures
Other
- Bachelor’s degree in Engineering or Scientific field with 6 years of relevant experience, or Master’s degree with 5 years of experience in industry or education.
- Manufacturing experience
- 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
- Travel Requirements: % not specified, but travel has occurred in the past on an as-needed basis for project continuity
