Edwards Lifesciences Senior Engineer, Advanced Process Development - New Product Development in Irvine, California
The Sr. Engineer, Adv. Process Development for New Product Development will contribute to the development and commercialization of new products and the development of new manufacturing process associated with novel medical devices improvements across our Critical Care Business. The Adv. Process Development Engineer will support Critical Care Operations by ensuring device design adheres to principles of DFM, leverage existing processes and/or implement new manufacturing technologies and methodologies.
In this role you will also be responsible for develop a robust manufacturing process with respect to the expected capacity, develop, test and validate manufacturing fixtures and/or equipment, coordinating process development activities between the project team and the manufacturing plants and/or suppliers. You will also be the subject matter expert on EW Process Development for the NPD team. You will be responsible for bringing issues related to all aspects of operations from the team into the broader EW organization and will be accountable to the team for performance of appropriate operational and supply chain activities by the extended team members.
The Sr. Engineer, Adv. Process Development will integrate both New Processes and Operational needs to develop a robust manufacturing process with respect to the expected capacity to support the Global Supply Chain strategy. In this role you will report to the Distinguished Engineer of Adv. Process Development- Critical Care.
Create, characterize, and implement new manufacturing processes including leading the design, procurement and qualification of manufacturing equipment and tooling for NPD/ VE projects.
Develop solutions to manage complex manufacturing process design, development and validation efforts from early product development through product launch.
Transfer processes from R&D to Manufacturing using project management, design for manufacturability and cost, process/design excellence, LEAN, ergonomics and knowledge transfer methodologies to ensure effective implementation of equipment, processes, and new technology.
Development of process specifications which ensure user needs are met
Perform equipment and process qualifications (TFIQ/IQ/OQ/PQ).
Drive incorporation of technical advancements into manufacturing process and technology employed in the manufacture of both existing and new products.
Work and effectively communicate in a high energy, cross functional team and multiple site environment which includes product design, regulatory, quality, procurement, supply chain, supplier quality and operations to ensure project objectives are met.
Continuously improve existing processes, manufacturability and sustainability.
Accountability (including hands on and resourceful) on troubleshooting, problem solving, and escalation of program risk to management when design transfer and scale-up to manufacturing do not work as expected.
Be the subject matter expert in key disciplines related to the manufacture of Class I, II and III medical devices.
Bachelor's degree in engineering discipline (e.g. Mechanical, Biomedical, Electrical or System Engineering.
Minimum of four years of experience on creating process from inception to validation, including process development and characterization.
Experience in the creation of automatic and/or semi-automatic inspection and/or assembly system strongly preferred.
Previous experience working with lab/industrial equipment required
A minimum of four (4) years of experience. Medical device manufacturing/ design experience is preferred.
Capable of analyzing and solving complex problems through innovative thought and experience.
Experience with key technologies and processes related to the assembly and manufacture of surgical instruments, stents, catheters, delivery systems, and/or interventional devices is preferred.
Proven expertise in usage of MS Office Suite; SolidWorks experience preferred
Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
Good understanding of statistical techniques for developing processes, such as Design of Experiments (DOE), range finding, and process capability studies
Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
Strong problem-solving, organizational, analytical and critical thinking skills
Demonstrated use of process and design excellence methodologies including Six Sigma.
Knowledge of Design for Manufacturability, and LEAN methodology.
Ability to develop process requirement/ specifications, collaborate with outside design firms and work with Operations personnel.
Demonstrated strong project management skills leading to cost savings w/ knowledge of cGMP, EHS guidelines, FDA guidelines, Supplier Quality and Process Validation.
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.