Edwards Lifesciences Staff Engineer Operations Product Manager - Critical Care (Irvine, CA) in Irvine, California
The dynamic role of Staff Engineer will guide and provide expertise in the design transfer of new products within the Critical Care GSC operations team.
Develop overall operations strategy, including but not limited to component sourcing strategy, manufacturing process development, test strategy, configuration management, and forward and reverse logistics implementation
Lead and establish complex project plans to ensure deliverables are completed to overall project team and contract manufacturer’s expectations, partnering with cross-functional NPD team and extended operations team
Support development build execution and coordination
Lead process control strategy and cascading of product requirements to manufacturing test and inspection points
Partner with contract manufacturer’s to develop new product manufacturing lines
Initiate, lead the identification, and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods)
Train, coach, and guide lower level employees on highly complex procedures
May be selected as an Independent Reviewer for design review
Other incidental duties
Education and Experience:
Bachelor's Degree in Engineering or Scientific field plus a minimum of 6 relative years experience
(or Master's Degree in Engineering or Scientific field plus 5 years relative experience)
Manufacturing engineer experience within regulated industry highly preferred (medical device, biotechnology etc)
Proven expertise in usage of MS Office Suite; CAD experience preferred
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
Strong leadership skills and ability to influence change
Ability to interact professionally with all organizational levels
Represents organization as key technical contact on projects
Interacts with senior external representatives on significant technical matters often requiring coordination between organizations
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.