Edwards Lifesciences Senior Engineer, Manufacturing in Irvine, California
The Sr. NPI Engineer provides support for new product introduction (NPI) activities for class III, implantable devices for Edwards' comprehensive portfolio of transcatheter heart valve replacement therapy. The Senior Engineer will advance the objectives of the Global Supply Chain Network by supporting supply chain development and associated engineering activities from early product development through product launch. This role is accountable for successful commercialization of new products. The Senior Engineer will also ensure manufacturing processes are developed that meets operational needs for capacity and scale while ensuring cross functional alignment across manufacturing sites in different locations including readiness at suppliers. The Senior Engineer will act as a liaison between R&D, supplier development, quality and sustaining operations to ensure readiness to seamlessly plan, source, make and deliver the product to customers around the world.
Support operational transitions through development, clinical, and commercialization including completion of design transfer deliverables to ensure end-to-end readiness
Work cross functionally with pilot, sustaining operations and, domestic and international manufacturing locations to harmonize transfer plans and validation strategies across all sites. Drive line and capacity expansion plans in manufacturing locations in collaboration with demand planning and commercial groups for uninterrupted product supply.
Drive and lead critical integration meetings to inform stakeholders across GSC and related functions on progress and risks. Ensure risks are clearly identified and addressed for smooth execution of development activities
Drive the development of supply chain strategies to attain operational efficiency including assessment of capital and operational expenses to support development needs of the products
Ensure development and implementation of robust characterization and validation activities in collaboration with partners from R&D and quality, including deployment of critical control points in manufacturing
Identify manufacturing and sale-up risks at pilot and production sites, and develop, implement appropriate mitigation plans, including business continuity plans at suppliers. Ensure clear alignment across sites to harmonize actions and site-to-site transfer of knowledge, process and practices as applicable.
Identify and drive continuous improvements in manufacturing processes including opportunities to incorporate digital strategy, automation initiatives, mistake proofing while elevating quality standards
Identify and ensure implementation of opportunities to optimize/improve related processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc. are up to standards
Ensures accuracy of part/drawings, bill of materials (BOM) and other manufacturing documentation. Leads the execution of playbooks to ensure successful assessment and deployment of sourcing, planning, transfer and supplier assessment by PDP phases.
Work with cross functional partners to ensure design for manufacturability considerations are incorporated into product and process designs, including design and process 3P across sites. Support MES deployment as needed
Provide analysis and tracks progress against agreed upon targets and deliverables to attain operational metrics required for successful commercialization of products
- Bachelor’s Degree in Engineering or Scientific field (mechanical, manufacturing, or industrial engineering) with 4 years of manufacturing experience (e.g. working with product, building, testing, etc.) (or Master’s Degree in Engineering or Scientific field (mechanical, manufacturing, or industrial engineering) with 3 years of manufacturing experience (e.g. working with product, building, testing, etc.)
Experience in medical device manufacturing preferred
Proven track record in design transfers to Operations and process and equipment validation
Understand injection molding, polymers, medical textiles and commonly used materials in the medical device space, such as Nitinol and implantables, with working knowledge of metals processing.
Experience in developing process requirement specifications, collaborating with external parties, suppliers and working with Operations personnel to establish efficient solution systems
Expertise in the area of manufacturing engineering: design for manufacturability, design and process excellence methodologies including Six Sigma, LEAN experience, cGMP, EH&S guidelines, supplier development engineering and process validation.
Excellent communication and interpersonal skills at all levels of employees including upper management, suppliers, operators and external parties.
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
Travel 20% domestically or internationally, if required.
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.