Edwards Lifesciences Senior Quality Engineer(NPD)– Surgical Structural Heart in Irvine, California
The Quality Affairs team in Surgical Structural Heart has an opening for a Sr. Quality Engineer to support New Product Development activities in applying 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 or assist with 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 or assist with the development and manage the execution of simple to 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 and initiate 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 simple to 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
• 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
Education and Minimum Requirements:
Bachelor's Degree in Engineering or Scientific field and 4 years of relevant experience in the medical device or another highly regulated industry (i.e. aerospace or automotive).
Master's Degree or equivalent in Engineering or Scientific field and 3 years of relevant experience in the medical device or another highly regulated industry (i.e. aerospace or automotive).
Ph.D. or equivalent in in Engineering or Scientific field and 2 years of relevant experience in the medical device or another highly regulated industry (i.e. aerospace or automotive).
· New Product Development engineering experience for a class III implantable device industry
Additional Talents and General Expectations:
• 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 EHS rules and requirements 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
• Experience with automation, software testing, and software validation is strongly preferred
20 % not specified, but travel (to suppliers) has occurred in the past on an as-needed basis for project continuity
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.