Edwards Lifesciences Senior Engineer, Manufacturing in Irvine, California
Sr NPD Manufacturing Engineer role provides support and oversight of new product development manufacturing engineering for a class III, implantable device for Edwards' comprehensive portfolio of treatments for structural heart disease within the Surgical BU. The Senior Engineer will support the Global Supply Chain Network by managing 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 that design and manufacturing processes are characterized, robust, scalable utilizing best technologies, reflect standard work, are capable and compliant with Regulatory requirements and are validated for Design Control, Manufacturing using LEAN Six Sigma, Design for Manufacturing and Design for Cost Methodologies. The Senior Engineer will act as a liaison between R&D, Supplier Development, Quality and Operations team members assigned to the project. The position will report to the Manager of NPD Engineering and work directly with the Manager of Ops Integration
Operations technical leader for new products in the PDP process and its main interface between R&D, Pilot, and commercial manufacturing
Support operational transitions through development, clinical, and commercialization phases and ensure completion of Design Transfer
Responsible for the development of applicable Process Development (IQ/OQ/PQ) protocols and provide support for execution of validation plans and reports
Manage pilot production builds, planning, tracking and execution
Drive the development and manage the execution of complex experiments and tests (including writing an executing protocols) on new or existing product lines to qualify and validate manufacturing processes, analyze results, make recommendations, and develop reports
Responsible for Characterization and Validation activities, including CTQ flow-down and identification of critical control points within manufacturing
Leads development of pFMEA
Deploy manufacturing risk assessment and mitigations, including hands on and resourceful action plans
Responsible for part/drawing release, and accuracy of the Bill of Materials (BOM)
Review engineering product specifications, CAD data/drawing, as part of design review process to ensure they meet industry and manufacturing standards and practices
Ensure DFM, Six Sigma, and LEAN considerations are incorporated into product and process designs, including design and process 3P
Provide analysis and track progress against agreed upon targets and deliverables
A bachelor’s degree in engineering is required.
Minimum of four years of manufacturing engineering experience is required.
Medical device manufacturing experience preferred
Proven track record in design transfers to Operations and process, equipment validation experience
Understand injection molding, polymers and commonly used materials in the medical device space, such as Nitinol and implantable, with working knowledge of metals processing
Experience in developing process requirement specifications, collaborating with external parties, and working with Operations personnel to establish efficient solution systems
Technical 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
Must be willing and able to travel up to 20% domestically, 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 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.