Edwards Lifesciences Associate Manager, Engineering in Irvine, California
This is a great opportunity to manage and/or lead a small team responsible for supporting general cleanroom support, as well as equipment tracking, calibration, maintenance, validation, troubleshooting, and repair.
Partner with marketing, R&D, RA, quality, and operations to develop process changes; including the design, development and procurement of tooling, fixtures and equipment.
Creation of detailed Manufacturing Instructions to support new processes and equipment.
Layout of production workstations for product flow, ergonomics and efficiency.
Specification of hand tools for assembly tasks.
Drive CAPA activities including verification, validation and implementation of improvements.
Resolve NCRs, ENCRs, and OOTs in a manner which minimizes impact to manufacturing activities.
Ensure compliance to quality requirements.
Ensure accuracy of FMEAs and Validation Plans.
Write and execute process validation protocols (IQ/OQ/PQ).
Identify opportunities and lead the implementation of changes to drive improvements.
Perform other duties and responsibilities as assigned.
Bachelor’s Degree in engineering with 8 years of engineering manufacturing experience.
Experience working in a regulated industry.
Master’s degree is preferred.
Ability to manage technical and/or engineering disciplines and demonstrated informal mentoring and/or peer leadership skills.
Proven successful project management skills.
Proven expertise in both Microsoft Office Suite and related systems.
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making.
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
Extensive understanding of engineering procedures while defining team operating standards.
Extensive understanding of related aspects of engineering processes and/or systems.
Basic financial acumen as it relates to engineering (e.g., material and capital expenditures and product costing).
Ability to influence cross-functional partners.
Ability to integrate metrics into the projects and operations.
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.
Ability to work and excel within a fast paced, dynamic, and constantly changing work environment.
Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
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.