Edwards Lifesciences Principal Engineer, NPD Electronics Assembly – Critical Care in Irvine, California
The Principal Engineer is an exciting opportunity that will provides expertise, leadership, and guidance in the development, and manufacture of life-sustaining critical care capital equipment. This role will join Edwards Critical Care division that is innovating at a rapid pace and seeking a seasoned veteran to support the Operations Team.
Essential job functions include:
Drive the development of highly complex manufacturing processes; Act as the technical SME for electronics design for manufacturability.
Partner with R&D to identify opportunities to optimize/improve manufacturing processes including using engineering methods, (e.g., DFx, Black Belt) and employing technical design skills to provide design feedback on new products.
Train, coach, and guide lower level employees on highly complex electronic assemblies best practices.
Lead and establish highly complex project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
Experience in the design and development of digital/analog boards and systems.
Experience in system-level design and architecture, including schematics and board development, system bring up and debugging.
Experience with the manufacturing process and design rules for PCBA, Flex Circuitry, System on Chip, Molding, Batteries, Pneumatics, and other relevant medical technologies etc.
Hands-on experience with sensor technologies and architecture.
Able to analyze the trade-offs between performance, manufacturability and cost.
Perform other duties and responsibilities as assigned.
Bachelor’s Degree in Engineering or Scientific field with 8 years of related experience; or Master’s Degree in Engineering or Scientific field with 7 years of related experience.
Proven expertise in usage of MS Office Suite; Matlab, Spice, other simulation/modeling experience preferred.
Familiarity with medical device regulations and governance documents (ISO13485, CFR820, IEC 60601-X).
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills,
Ability to translate complex and technical information to all levels of the organizations.
Recognized as an expert in own area within the organization while applying broad-based technical expertise and has full knowledge of other related disciplines.
Expert knowledge and understanding of principles, theories, and concepts relevant to Engineering.
Advanced problem-solving, organizational, analytical and critical thinking skills.
Expert understanding of processes and equipment used in assigned work.
Strong leadership skills and ability to influence change.
Ability to interact professionally with all organizational levels.
Represents organization as key technical contact on contracts and projects.
Interacts with senior external representatives on significant technical matters often requiring coordination between organizations.
Travel up to 25% of the time to domestic contract manufacturers.
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 13,000 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.