Michael Diroma Email & Phone Number

San Diego, Ca, Us

San Diego, California, United States

San Diego, Ca, United States

Campbell, Ca

Campbell, Ca

• Responsible for manufacturing support, process innovation and cost improvement.• Demonstrates ISO13485 compliance.• Establishes manufacturable processes on projects exiting Design Services and/or Pilot Manufacturing.• Ensure all project specifications are verifiable prior to transfer to Production.• Hands-on implementation of Lean manufacturing techniques and use of the Theory of Constraints to optimize production throughput while maximizing labor utilization.• Provides leadership, training and support to the facility operations in an effort to eliminate non-value added activities in all manufacturing and administrative processes and radically improve cycle times as they impact our customers.• Provides technical leadership in the areas assigned and provide Design for Manufacturing; input to R&D, customers, and product commercialization teams.• Designs and implements new tooling, fixturing, and capital equipment.• Writes all essential documents (i.e. MPI’s, Inspection Plans, LHR’s, DMR’s, Validation Processes, and Calibration Requirements) to FDA.• Works closely with R&D Engineering group to assist and coordinate project transfers from R&D phase to Manufacturing phase.• Familiar with product requirements, concept prototyping, design and development (including verification and validation), risk/failure mode assessment, performance and safety testing.• Coordinates time and activities of others and/or serve as a project leader for cross-functional programs.• Maintains detailed documentation throughout all phases of manufacturing development and transfer phases.• Reviews and coordinates outside vendor activities to support development.• Manages and develops technical solutions to design problems with vendors and in-house resources through design reviews, design audits, and prototype analysis.• Interface with customers and internal departments articulating team activities and progress.• Knowledgeable with ISO 13485, 21 CFR Part 820.

Scottsville

• Extensive experience in IQ/OQ/PQ validation process as well as factory/site acceptance testing.• Successfully managed multiple CAPA implementation projects.• Actively lead teams to overcome various technical challenges through the use of lean six sigma tools including value stream maps, fishbone and pareto analysis.• Consistently apply statistical methods and designed experiments to manufacturing process optimization.• Maintain device history records, across multiple departments, related to change orders and process development in order to support engineering staff during a potential audit.• Design, test and implement various tooling and fixtures to support production operations.• Work in conjunction with machine builders to develop new production equipment as well as the process surrounding the equipments use.• Define functional specifications and user requirements for new equipment.• Develop robust experiments to evaluate the feasibility and/or effectiveness of proposed engineering changes.• Instrumental in executing engineering change orders and providing all support documentation.• Provide functional support or project lead for various unique projects as requested by upper management.• Managed validation of several new equipment implementations, including development of multiple contact lens manufacturing processes, both manual and fully automated.• Work closely with quality engineering to ensure regulatory compliance and develop/review standard operating procedures, validations, design charts and critical forms.• Assure adherence to ISO 9000 requirements including creation and approval of standard operating procedures.• Experience working within medical device and risk management related ISO standards, ISO13485, ISO14791 and 21CFR820.

• Engaged in fundamental IE tasks such as time studies, 5S initiatives and various lean improvements.• Drove cost reductions through equipment optimization, process yields and labor productivity.• Worked closely with molding process engineers to monitor and maintain control of injection molding processes.• Gained thorough knowledge of the MTO manufacturing process and how it drives a customer focused model.• Standardized 60+ pieces of production equipment to better diagnose mechanical failures/reduce periods of downtime by employing a predictive maintenance strategy.• Managed facility layouts and conducted space utilization analysis.• Implemented a site wide statistical process control package via InfinityQS suite.• Developed production control reporting infrastructure to continuously monitor process control and capability.• Experienced in precision cast molded and lathed lens manufacturing of toric, multifocal and single vision contact lenses.• Performed quality driven exercises based in acceptance sampling, risk mitigation, gage studies and process capability analysis.• Gained approval of various validation protocols, including design specifications for soft contact lenses.• Performed a wide range of engineering studies to support subsequent validation efforts.• Implemented several key pieces of advanced metrology to elevate the precision of the contact lens manufacturing process including interferometers, Shack-Hartmann array technology, automated imaging microscopes and NIMO lens mapper.• Experience in an FDA regulated environment has required an elevated level of GMP compliance as well as in depth knowledge of various statistical evaluation methods.

Master’S Degree, Industrial Engineering

Bachelor Of Science - Bs, Industrial Engineering