Juan Ceballos
West Palm Beach,FL
Summary
Seasoned Engineering Manager/Contractor adept at seamlessly integrating project technical aspects and making information relatable to non-technical personnel. Experienced leader and program manager with 13 year history in the medical device field. Clear communicator, decision maker and problem solver.
Skilled leader with strong background delegating tasks to various employees. Adept at staff training and adhering to safety procedures. Successful at choosing and training talented employees and paying close attention to project details for success. Meets daily goals by streamlining processes and organizing tasks.
Overview
22
22
years of professional experience
Work History
Equipment/Facility Maintenance & Calibration Lead
Flex
01.2023 - 05.2023
- Development and implementation of the Engineering Maintenance Program for the Glucose Meter Manufacturing Areas (Glucose Meter Libre 2 & 3) for The Buffalo Grove, IL and Austin, TX facilities.
- Development and implementation of the Equipment Calibration Program for The Buffalo Grove, IL and Austin, TX facilities.
- Review, Upgrade and Implementation of the Statistical Techniques SOP used by the medical manufacturing engineering in Flex.
Sr. Engineer Consultant
Boston Scientific
01.2020 - 10.2022
- EU MDR Assessment of Medical Devices: Manage the Design Control (DHF), Design Transfer, Design Traceability Matrix, Production and Process Control, and Change Control expertise, including design verification, design I/O, design validation, Design Software Verification, and Verification for International Standards Compliance
- Product Usability (IEC 62366) and Risk Management (ISO 14971) Assessment/ Remediation Expertise., EU MDR Assessment & Remediation for Israeli Acquisition of Lumenis Medical Lasers & Optical Fibers.
- Finalized project plans and obtained approval from clients.
- Published engineering documentation relating to development of solutions for process validations.
- Consulted with Subject Matter Experts (SMEs) to resolve technical issues that arose during product review and assessments.
- Edited technical documentation for clarity and conformity with overall goals, safety guidelines and regulatory compliance.
Sr. Engineer Consultant
Terumo Medical Corporation
08.2021 - 01.2022
- Design transfer and change control assessment for EU MDR NB Certification
- FemoSeal Vascular Closure Device - EU MDR Assessment
- Angio Seal VIP Vascular Closure Device - EU MDR Assessment
- Processed technical feedback reports from quality engineering staff, integrating suggestions and reported issues into remediation engineering tasks.
- Supported project planning and execution efforts relating to technical documentation and process development.
- Edited technical documentation for clarity and conformity with assessments goals and regulatory compliance.
Sr. Design Control Consultant
Boston Scientific
04.2021 - 08.2021
- Design Control EU MDR ASSESSMENTS (100% Remote Support Project): HPS Laser System & Laser Fibers EU MDR Assessment; New Generation UroMax Balloon Catheter; XPS Laser System and Laser Fibers; Lumenis Holmium and CO2 Lasers EU MDR Gap Assessment & Remediation.
- Identified design requirements for each project.
- Analyzed feedback from customers and staff to refine design concepts.
- Reviewed project requirements to plan workflows and evaluate client time and budget constraints.
Sr. Design Control Consultant
Hologic
07.2020 - 04.2021
- Design Control EU MDR Assessment (100% Remote Support Project)
- ISO 13845 & EU MDR Design Control DHF Gap Assessment including: design input, design output, design verification, design validation, design review and design transfer phases documentation review for 1- Endometrial ablation (Intrauterine Tissue Removal) DHF Regulatory Assessment for NovaSure Advanced Ablation Device and NovaSure Controller Unit
- 2- MyoSure Hysteroscopic Tissue Removal Devices (LITE, REACH, FLUENT and New Generation XL Devices), MyoSure Controller 10-550, and Fluid Management System Controller
- EU MDR Gap Assessment Report and Remediation Project for NovaSure and MyoSure Products
- Test Method Validation Gap Assessment for the Design Control Review in both Medical Devices.
Sr. Process Validation / TMV Lead
Natus – Schaumburg, IL
10.2019 - 07.2020
- Lead and Performed Test Method Validation Gap Assessments Project for the neoBLUE Blanket (Neonatal products) as part of the 483 Warning Letter CAPA Project
- CAD Test Fixture design, and Fixture IQ validation
- Drafting and planning the TMV remediation activities
- Labeling support to the Global Natus Labeling Project
- Schaumburg, Managed Software Master Validation Plan and lead the Hearing Products Software Validation project
- Validation of the SoundCheck 16 Software for R&D use
- Lead the Test Method Validation Validations for Echo-Screen III, ALGO 3i, and ALGO 5 infants hearing screening devices
- Managed the creation and release of protocols, their execution, and reports
- Lead TMV Team in the Sampling Plan selection and final Statistical Analysis
- Lead the
- DPOAE/DPOAE+ TMV Protocol Execution and Report
- Clip/Chirp ATA TMV.
Sr. Quality Consultant
Arthrex
06.2018 - 08.2019
- Validation the UDI Laser Marking Equipment for Orthopedic Implants
- Engineering Study Protocol (Robust DOE) for Laser Marking of Titanium, SS, and Peek
- Software Validation for FOBA Laser Marking Software – MarkUS 2.11
- IQ, OQ and PQ Validation of the FOBA Laser System M3000P
- Master Validation Plan Report Update.
Sr. Quality and Regulatory Consultant
JUUL
10.2018 - 05.2019
- Develop and manage the Master Validation Plan for e-cigarettes New Production Lines deployed in Hungary Sárvár’s Flex facility
- Support the Company in multiple engineering roles as:
- Laser Safety Assessment for Contract Manufacturers Factories in Suzhou China and Buffalo Groove, IL
- Support the automation engineering team in San Francisco, CA for new production equipment User Specification Review for the 100% Automation operation in Sárvár\\, Hungary
- Support the Laser Marking Equipment design team, to provide highest manufacturability grade
- Support the Sárvár’s Flex Facility (Hungary) Process Validation Activities
- Support the Quality System Team by Developing Validation Protocols (IQ-OQ, PQ), execution and review/disposition the corresponding Validation Reports
- Support e-Liquid CAPA Project
- Support the Quality System Team Improve the Statistical Analysis SOP, by reviewing and upgrading the Company Statistical Method SOP, and Sampling Plan SOP
- Support the Review of the Process Validation SOP and IQ, OQ, and PQ Protocol/Report Templates.
TMV Project Lead
Cook Medical
09.2018 - 10.2018
- (Balloon Catheter Measurement System Validations)
- Provide Training to Junior engineers and improve the Incoming Inspection Measurement Systems
- Develop TMV Protocols, released and approve Validation Reports.
Sr. Management Consultant
NuVasive, Inc
06.2018 - 08.2018
- Support the Quality Team in CAPA investigations
- Evaluated diverse organizational systems to identify workflow, communication, and resource utilization issues.
- Improved product development process by incorporating design for Six Sigma.
- Broadened improvement initiatives, troubleshooting problems for corrective action.
- Evaluated current processes to develop improvement plans.
- Produced detailed and relevant reports for use in making business decisions.
- Skilled at working independently and collaboratively in a team environment.
- Support to the Management Team in Manufacturing Operation, Problem Solving, and Yield Improvement activities.
Lead Test Method Validation Consultant
BD - Becton & Dickinson
01.2018 - 05.2018
- Lead and Performed Test Method Gap Assessments Project for the Mechanical Engineering as part of the 483 Warning Letter CAPA Project
- Drafting and planning the TMV remediation project, and all the required validation protocols and report templates.
Senior Validation Consultant
Caesarea Medical Electronics, Ltd
10.2017 - 12.2017
- Lead the Master Validation Plan Draft, approval and planning
- Support the validation activities.
Senior Quality Engineer Consultant
NuVasive
08.2017 - 10.2017
- Ti Anodizing Process Improvements and Analytical/Test Laboratory setup and management
- NCMR Investigations and CAPA support for the Ti and Peek CNC Milling, Anodizing, Passivation and Final Implant Assembly Area
- Anodizing Analytical TMV Protocol at Chem lab for controlling the daily anodizing and passivation processes chemical solutions.
Eng. Program Manager & Sr. Regulatory Consultant
Oscor Inc
01.2017 - 09.2017
- Program Manager R&D and New Product Introduction Projects - Director Level Role
- Manage Product Transfer Project for Edward Life Science TVAR (Israel-Dominican Republic)
- Quality and Regulatory Senior Consultant leading remediation project for FDA responses to warning letters, and observations in CAPA, Post Market and Risk Evaluations (HHEs)
- Development of TMV procedures, protocol, and report templates
- Improve the CAPA SOP and the establishment of Problem Solving and Process Improvements Methodology for the Corrective Action Process
- Engineering Program Manager, leading the R&D Department in projects related to Medical Devices Design, development and manufacturing deployment, including technology transfer to customer sites
- Support the validation team in process validation, TMVs, and risk analysis and risk management SOP improvements.
Senior Regulatory Consultant
Zimmer
11.2016 - 01.2017
- Support the Post Market Surveillance Department in the Execution, and disposition of the open HHEs and couching of the engineering team on the HHE process
- Review and disposition answers to FDA audit observations
Project Manager/ PSC Project Lead
Philips Healthcare
04.2015 - 10.2016
- Project manager of field change orders (FCO) for Philips Imaging System involving:
- Software Updates to BIOS for servers in the field per CT systems specifications due to hardware updates
- SCR1.0 Software changes validations for the X-Ray Imaging systems CT Brilliance 16 Air, and 64
- CT Pediatric Brain Imaging failures due to X-Ray artifacts in Infants, and other projects
- Manage projects (end to end) and facilitate execution of AMI (Advance Molecular Imaging) and CT (Computer Tomography) Product Safety Committee (PSC) projects
- Develop HHE dispositions based on investigations of the Health Hazard and support the remediation projects
- Support the CAPA Team in the Root Cause Analysis Phase, and the SPC Implementation in Multiple CAPAs.
Senior Validation Consultant
Atrium Medical Devices
12.2013 - 04.2015
- Perform Manufacturing Processes Audits to the Stent, and the IV Product Line as part of a warning letter/remediation project
- Development of Test Method Validation Protocols, Report, Feasibility Testing, and No-Validation Rational TMV.
Principal Engineer
SYNEO - Florida Facility
09.2012 - 01.2013
- Laser Applications
- Design, manufacture and sales of Laser Systems for Medical Devices Manufacturing
- Titanium, NP35N, NiTi and 304 SS Wire Laser Welding Process Development and Validation
- PLC Programming for the Laser systems fixture, and HMI programming and integration into the production products
- Software validation for Laser PLC Program.
Supplier Quality Engineer
Philips Healthcare
02.2012 - 08.2012
- Perform Supplier Quality Assurance and engineering duties, to remediate and improves the Computer Tomography (CT), Nuclear Medicine (NM) and Magnetic Resonance (MR) imaging products in the Cleveland Facility
- Review and improves the Couch (patient table) installation in the manufacturing of Computer tomography imaging system using Class II laser systems
- Optimize supplier AOI (Automated Optical Inspection) methodology for the Time of Flight (TFE) PCB manufacturing, in the Alabama facility (Sanmina – SCI)
- Software Vendor/Supplier evaluations, and selection rational evaluation and SCAR procedure improvement.
Lead Process Development
Med Venture Technological Center
06.2011 - 01.2012
- Provided input/approval for design verification, and validation (Including software) testing of new designs and design changes to ensure product design quality and integrity
- Creation of protocols, and implement validation testing for products, establishing acceptance criteria and evaluating design changes
- Performed CAPA/NCMR investigations
- Executed and lead the Process Development
- Review specifications to ensure appropriate quality system, compliance, design, dimensioning, and tolerance stack-up review for manufacturing assembly
- Develop the Laser Welding Process for the St
- Jude Medical Heart Valve Design (Titanium based)
Sr. Manufacturing Engineer
Boston Scientific Corporation
04.2010 - 04.2011
- Main engineer resources in laser processes repair and troubleshooting (Miami Plant)
- Re-design of the optical system for the focusing system of the Nd: YAG lasers in the welding processes
- (For different production lines)
- Develop protocols, and reports for the IQ and software validations
- Developed CAPA/CAR Investigations, performed and implemented corrective actions
- Support the Project Transfer Team in the transfer of laser processes to the manufacturing plant BSC Heredia – Costa Rica
- Training to the Costar Rica technicians and engineering team in optics and lasers applied to manufacturing of Guidewires.
Manager of Engineering
Argon Medical Device Inc
01.2009 - 01.2010
- Organize, plan and lead Manufacturing Processes Technical Audits to comply with FDA CFR 820/ISO 13485 for the IV Sets production area, and general catheters-lab production areas
- Training to the engineering team in Process and Software Validations
- Teaching TMV & DOE methodology to engineering group, and coach the team through the execution of TMV as part of multiple Six Sigma Projects in Catheter Manufacturing
- Improved the optical inspection equipment in the manufacturing floor
- Managed engineering department budget and ensures conformance
- Served as member of management committees on special studies
- Lead Engineering team in Process Improvement and Problem-Solving Projects
- Train in Six Sigma methodologies engineers and technicians
- Coach Project Management and Team Work to projects leads
Sr. Process/Manufacturing Engineer
Heartware Inc
03.2008 - 11.2008
- LabView program software testing, implementation and validation for the LVAD heart pump testing equipment
- Nano-Metrology of Surface Texture Parameters Test Method Validations
- Stylus profilometer surface roughness measurement Test Method Validation
- Training to ASME, ISO and ANSI standards on Surface Texture Inspections
- Training of Technicians and Engineers in the use of Stylus Profilometer.
Manufacturing Engineer
Boston Scientific Corporation
01.2003 - 03.2008
- Lead the Optics and Laser related projects as the subject matter expert in Boston Scientific Miami Plant
- IV Catheters Manufacturing Process Improvement and SPC Implementation Cardiovascular Catheters Production ME
- Laser micro-soldering improvements for PT2 Guidewires (NiTi-SS)
- Improved yields of PT2 Catheter product line
- Provides technical support to engineer/technicians on Diode and Nd: YAG laser operations.
Laser Application Engineer
JPSercel Associates Inc
09.2001 - 08.2003
- Opto-Mechanical design of the Excimer lasers Beam Delivery using ZEMAX
- (Trained in optical design software)
- UV Laser Materials processing at 335nm, 308 nm, 266 nm, 248 nm, 193 nm and 157nm
- Micromachining of polymers, ceramics, hard dielectrics, glass and metals 1 | Page 2 | Page
Education
Master of Science - Physics - Applied Photonics and Nuclear
University of Waterloo
Waterloo, ONBachelor of Science - Physics, Optical Design and Laser Applications
Universidad De Oriente
Santiago De Cuba, Cuba07.1987
Skills
Extensive Program/Project Management Expertise
Advance Technology Expertise for the Medical Device Manufacturing
- Problem Detection and Resolution
- Equipment Troubleshooting
- New Equipment Design
- Cost Documentation
- Maintain Equipment
- Regulatory Standards
- Scheduled Maintenance
- Mechanical Inspection
- System Maintenance
- Technical Documentation Interpretation
- Preventive Maintenance Scheduling
- Performing Maintenance Procedures
- Equipment Assembly
- Functional Part Calibration
- Root Cause Analysis
- Troubleshoot Malfunctions
- Equipment Testing
- Safety Management
Accomplishments
- Manage PMS Remediation Project for Philips Healthcare and lead cross-functional consultant team in the Supplier Quality Department
- Process Validation: Lead Master Validation Plan Development and implementation including Test Method Validation (TMV), Software Validation (SV), Installation Qualification (IQ), Operational Qualification (OQ); Performance Qualifications (PQ)
- Note: PMP Institute Member ID: 5030911
- Undergoing Project Management Training for the PMP Certification.
Languages
English
Native or Bilingual
Spanish
Native or Bilingual
French
Professional Working
Timeline
Equipment/Facility Maintenance & Calibration Lead
Flex
01.2023 - 05.2023
Sr. Engineer Consultant
Terumo Medical Corporation
08.2021 - 01.2022
Sr. Design Control Consultant
Boston Scientific
04.2021 - 08.2021
Sr. Design Control Consultant
Hologic
07.2020 - 04.2021
Sr. Engineer Consultant
Boston Scientific
01.2020 - 10.2022
Sr. Process Validation / TMV Lead
Natus – Schaumburg, IL
10.2019 - 07.2020
Sr. Quality and Regulatory Consultant
JUUL
10.2018 - 05.2019
TMV Project Lead
Cook Medical
09.2018 - 10.2018
Sr. Quality Consultant
Arthrex
06.2018 - 08.2019
Sr. Management Consultant
NuVasive, Inc
06.2018 - 08.2018
Lead Test Method Validation Consultant
BD - Becton & Dickinson
01.2018 - 05.2018
Senior Validation Consultant
Caesarea Medical Electronics, Ltd
10.2017 - 12.2017
Senior Quality Engineer Consultant
NuVasive
08.2017 - 10.2017
Eng. Program Manager & Sr. Regulatory Consultant
Oscor Inc
01.2017 - 09.2017
Senior Regulatory Consultant
Zimmer
11.2016 - 01.2017
Project Manager/ PSC Project Lead
Philips Healthcare
04.2015 - 10.2016
Senior Validation Consultant
Atrium Medical Devices
12.2013 - 04.2015
Principal Engineer
SYNEO - Florida Facility
09.2012 - 01.2013
Supplier Quality Engineer
Philips Healthcare
02.2012 - 08.2012
Lead Process Development
Med Venture Technological Center
06.2011 - 01.2012
Sr. Manufacturing Engineer
Boston Scientific Corporation
04.2010 - 04.2011
Manager of Engineering
Argon Medical Device Inc
01.2009 - 01.2010
Sr. Process/Manufacturing Engineer
Heartware Inc
03.2008 - 11.2008
Manufacturing Engineer
Boston Scientific Corporation
01.2003 - 03.2008
Laser Application Engineer
JPSercel Associates Inc
09.2001 - 08.2003
Master of Science - Physics - Applied Photonics and Nuclear
University of Waterloo
Bachelor of Science - Physics, Optical Design and Laser Applications
Universidad De Oriente
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