Bruno Calderon Roman

• Inspects, aligns, troubleshoots, and repairs PMEL standards, common and weapon system peculiar Test Measurement Diagnostic Equipment (TMDE).
• Using theories of operation, block diagrams, schematics, logic trees and software diagnostics performs equipment inspection and maintenance.
• Calibrates and certifies TMDE to technical data specifications ensuring traceability to Air Force Reference Standards.
• Records and reports maintenance data; prepares technical order improvement reports, special training requests, training quality reports and modification proposals.
• Handles labels and disposes of hazardous materials and waste according to environmental standards.
• Coordinates lateral support, command certification, or contrat services.

• Develop MPIs and SOPs for R&D and Production of Drone to be tested at DoD competition.
• Purchase necessary tooling and supplies for development and production.
• Train and oversee team to ensure goals are met in a timely manner
• Provide feedback to engineering team on streamlining processes and testing.
• Coordinate tasks to support Operations and Engineering
• Assemble Fuselage with off the shelf components
• Inspect and test incoming PCBA boards for discrepancies
• Inspect Electro Mechanical sub assemblies in WIP with Digital multimeters for shorts and continuity.

POSITION DESCRIPTION

Implement engineering efforts directed by the Director of Advanced Operations. Assist in the overall Manufacturing and Operations for all programs and projects. Support the production and manufacturing of new technology projects within the company. Provide support/guidance for manufacturing of the company’s product line, from initial concept stage design, through verification, production and into initial clinical evaluation & commercialization. Products manufactured are done so in accordance with the Quality Management System and company objectives and timelines. Provide information and direction to senior management team regarding product processes, developments, and enhancements. Train, support, and work with third party manufacturing firms to produce products.

ESSENTIAL FUNCTIONS

• Provide on-going technical documentation support to production equipment, process or design related issues.
• Implements changes to continuously improve manufacturing systems in terms of quality, cost, cycle time, and capacity.
• Author and maintain accurate documentation of processes and production of products.
• Work with other engineering, clinical and regulatory affairs, sales and marketing, and quality assurance staff to coordinate development of technical documentation of new products.
• Assures business affairs are conducted according to established company policy.
• Assists in company product development milestone implementation and realization.
• Interacts with contract manufacturers.
• Performs product manufacturing and assembly activities as needed.
• Supports maintaining the manufacturing procedures.
• Maintains product design and quality system document files as needed.
• Implements quality-related functions associated with product development and manufacturing.
• Performs additional responsibilities as assigned.
• Inspect PCBA Boards for shorts and continuity using Digital Multimeters.

• Oversee all CER related activities related to Production and R&D.
• Trained and supervise 16 assemblers on 2 different production departments Monitor and Disposables.
• Generates Lot numbers on ERP system and issues LHRs to Monitor and Disposables.
• Facilitate time studies for all current and new procedures to with the goal of cost reduction.
• Ensure GMP and GDP regulations are followed.
• Disposition and close out LHRs for QA review for all CER activities and when needed the Monitor as well .
• Set up and responsible for all CDA lines.
• Attends cross functional meetings between Production, QA, Materials, Engineering, and R&D to support Advanced Operations.
• Helped Engineering draft and redline CER procedures for Loctite Benchtop Dispenser Robot, Zaxis HD Multifunctional Leak Tester, Nordson EFD, UV Curing systems: LX500 Omnicure, S2000 Omnicure and CL30 Loctite LED Flood System.
• IQ/OQ Loctite Dispenser Robot, All EFD equipment, Zaxis Leak testers and UV light curing systems and maintain proper records.
• Managed Production quotas during scale up to supply contract manufacturer in Tijuana, Mexico and coordinate regular shipments.
• Trained and supervised contract manufacturer employees in English and Spanish.
• Travels to Contract Manufacturer sites to train employees.
• Facilitate R&D Builds.
• Works closely with QA to disposition NCRs and rework instructions.
• Dispositions and close out Service Documentation for QA review in Monitor Department.
• Design and develop Fixtures on SolidWorks for prototyping.
• Work with engineers and technicians to resolve line issues and develop improvements to reduce cost.
• Use Digital Multi Meters to trouble shoot faulty PCBA boards.

• Assemble components into medical devices in accordance with approved manufacturing procedures.
• Perform in-process quality checks on sub-assemblies and finished product.
• Utilize small hand tools, calibrated instruments, measurement equipment, microscopes, test fixtures or other process equipment.
• Participate in line meetings as needed .
• Work with engineers and technicians to resolve line issues and suggest improvements.
• Maintain clean room integrity by using proper attire and adherence to clean room environment practices and procedures.
• Maintain accurate records/documentation related to quality, work in progress, test results, labor (e.g. timecards), and special projects.
• Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, and FDA regulations.
• Cross-train various process steps.
• Can train others to perform operations that the incumbent is proficient in.
• Work with Manufacturing Engineering and R&D on special projects, tests, or tasks as required.
• Perform in-process quality checks on sub-assemblies and finished products.
• Work with engineers, quality assurance, and technicians to resolve line issues and suggest improvements.
• Maintain accurate records/documentation related to quality, work in progress, tests results, and special projects.
• Review and correct LHR’s as assigned.
• Assist in directing line balancing to maintain lean flow.
• Use Digital Multi Meters to Check power sources for equipment used on the line.
  

• Assemble components into medical devices in accordance with approved manufacturing procedures.
• Perform in-process quality checks on sub-assemblies and finished product.
• Utilize small hand tools, calibrated instruments, measurement equipment, microscopes, test fixtures, and other process equipment.
• Work with engineers and technicians to resolve line issues and suggest improvements.
• Participate in line meetings as needed .
• Maintain accurate records/documentation related to quality, work in progress, test results, and special projects.
• Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, and FDA regulations.

• Maintained high quality customer satisfaction 
• Ensured FDA and Food Safety regulations 
• Managed crew members at a 24hr location both day and night shifts 
• Generated weekly schedules 
  
• Made sure that products were produced on time and are of good quality