Principal Quality Engineer; Process

A Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Principal Quality Engineer (Process) position is a unique career opportunity that could be your next step towards an exciting future.

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.

• 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.

• Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.

• Other incidental duties.

• Bachelor’s degree in Engineering or a Scientific field with 6 years of industry or industry/education experience, or Master’s degree (or equivalent) in Engineering or a Scientific field with 5 years of industry or industry/education experience required.

• 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…