Jesús Parrilla

Lead the end-to-end NPI process by collaborating and managing cross-functional teams to ensure seamless integration / launch of new products in the site. Plan, design and build initial manufacturing line to support design validations, equipment validations and concept feasibility studies for new product introductions. Work closely with R&D to manufacture and supply catheters for clinical trials to validate the design at different regions worldwide. Collaborate with R&D to identify and solve design problems before product scale-up. Communicate to stakeholders and upper management the progress of the project. CapEx estimation and management. IQ, OQ, PQ, TVM, Gage R&R, DVT.

•Juarez Engineer Lead responsible of transfer and launch new products achieving the yield output required to transfer the product to manufacturing department. •Define project timeline according to company needs. •Responsible of developing spending plan thru the project life. Quote, place and follow up purchase orders for equipment needed. •Coordinate the generation and release of all appropriate documentation for mass production. •Coordinate shipping of samples to other facilities for clinical trials, elaboration of customs paperwork. •Lead the introduction of new equipment/fixtures to the manufacturing line since prototype phase, develop maintenance routines, process instructions and visual aids. •Coordinate Gage R&R studies to validate equipment and in-process / final inspections. •Develop 3D model and 2D drawings of new fixtures / equipment following ASME Y14.5 standard. •Define parameters of new equipment / process using DOE methodology. •Design and coordinate facility needs installation. •Coordinate training deployment in conjunction with the training coordinator. •Define validation plan and coordinate validation activities. •Review and approve validation protocols (IQ, OQ, PQ, TMV), test reports and engineering studies. •Work with R&D, QE and manufacturing engineers in DFM workshops in early phases of new products. •BOM analysis, scrap factor for components. •Implementation of engineering changes. •Responsible of investigate and analyze scrap to reduce failures. •Provide to RI all equipment, documentation, procedures needed to receive, inspect and approve new components.

EU MDR (Medical Device Regulation) Site Lead. Translate MDR 2017/745 requirements into local requirements from an end-to-end perspective. Implementation and validation of new procedures to address the creation, change control, maintenance, and periodic reviews of MPIs (Manufacturing Process Information). Integration of new procedures into the Biosense Webster Quality Management System. Coordinate the creation of MPI documents across Biosense Webster manufacturing sites (US – Mexico). Assess the impact of ECOs (Engineering Change Orders) in MPI Documents and update accordingly. Global support to other Johnson and Johnson sites. Global support to regulatory affairs team in product submissions / approval. Coordinate training deployment to manufacturing engineers for a successful ownership transition.

Coordinate the implementation and validation of new products. Quote, purchase and install new equipment (Molds, punching machine, laser machine for back plates). General support to R&D department (Prototypes, analysis of new materials for cost reduction). Coordinate and implement ECN’s in production floor. Create BOMs for new part numbers. Support to procurement and planning team to reduce inventory levels Coordinate site-to-site product transfers. Inventory management based on customer demand for product transfer Coordinate equipment transfer.