Summary
Overview
Work History
Education
Skills
Websites
Certification
Generic
Edgardo Arce

Edgardo Arce

Sr. PM Engineer / SCRUM Leader / OpEx
CALIFORNIA

Summary

Talented PM and Engineer professional considered knowledgeable leader and resolute analytical person. Brings +19 years of valuable expertise in Medical Devices to forward company objectives. Attentive to detail with experience in coordinating and executing projects, programs and process improvements aligned with FDA and ISO 13485:2016 requirements.

Overview

19
19
years of professional experience

Work History

Program Manager

JABIL HEALTHCARE (Contract Manufacturer)
2018.12 - 2023.11
  • Line Transfer Lead for Project Raptor "Cerenovus" (Cerenovus as product manufacturer of Micro Assembly Coils for aneurism treatment with 161SKUs and 10M Revenue). Sending site JnJ Cerenovus Fremont, CA to Receiving site: Jabil BAJA (JHB3), +2 years transfer timeframe.
  • Line Transfer Lead for Project Dayton "Ethicon Endoscopy" (Ethicon as product manufacturer for Endoscopy Products: Focus, ERCA, MCA, ACE+ as examples). Sending site JnJ Ethicon Juarez Mx Site to Jabil BAJA (JHB3). 2 years transfer timeframe.
  • Jabil JHB3 Clean Room Start Up with 80,000sqft & Validation Coordination.
  • Integrate Project Management Plan and coordinate cross functional workstreams: Resource, Supply Chain, Equipment, Quality, Customer Documentation & IT System (SAP & MES)
  • Direct Communication and Summary Reports to Jabil senior management and directors around project status, constraints, and critical issues
  • Monitor and Control project progress with risk management applying lesson learned from previously transfer implemented in Jabil and other Medical Companies across experience gained
  • Working with Corporate PM-PMO on Project Validation Standardization & Strategy Plans
  • Leading and executing the work defined in the project management plan
  • Working on develop NPI Process Standardization to help other PMs to provide guidance on implementation as continues improvement plan for NPI process.

Continuous Improvement Engineer

MEDTRONIC
01.2014 - 12.2018
  • Responsible to coordinate and execute Medtronic Operating System & Cell Operating System work-flow transformations plan according with Medtronic vision
  • Responsible to identify and execute cost reduction projects on different accounts (MAT, LAB, FOH and VOH)
  • Saving above 1MM on Fiscal year
  • Keep close monitoring of each of the major cost reduction projects assuring progress according to plant and providing effective support to project leaders/teams
  • Document OpEx process related to financial validation, budgeting and forecast saving estimation process with active communication to management
  • Active participation on continuous improvement initiatives: Kaizen Events, Gemba walks, 5’s program, Behavior Based Quality (BBQ), Value Stream Map, PDCA, Kanban & Change Overs with more than 40 kaizen event experience as team member and/or team leader.

Sr. Project Engineer

COVIDIEN
11.2010 - 01.2014
  • NPI New Product Introduction; Participation as project leader and main point of contact for external groups (R&D, Packaging, Labelling and Marketing)
  • Close monitoring on project executions according to plan and effective communication to all levels on the organization
  • Engineers, Technician & Interns direct supervision during project execution
  • Responsible to product/process validation (IQ, OQ & PQ) as project leader.

Sr. Manufacture/Industrial Engineer

COVIDIEN
03.2005 - 10.2010
  • Responsible to a close monitoring to key process indicators (Productivity, Scrap, NCR’s & Complaints) with continuous improvement plans generation
  • Experience on Problem Solving Methodology’s application (PDCA, 8’D, Ishikawa, DMAIC A3, 5’whys) to implement corrective and preventive actions for product non-conformances Responsible for Manufacturing Cells Design Transformation and Line Balance according to Takt time.

Education

Bachelor Degree On Industrial Engineer (Manufacture) -

ITT - Instituto Tecnologico De Tijuana
Tijuana, MX
01.2001 - 01.2005

Skills

  • 19 Years of Experience on Medical Industry Class II (Implantable) and III (Disposables) Devices
  • SCRUM Framework (Agile Methodology)
  • Leadership & Strategic Planning for NPD/NIP
  • Resource / Risk Management
  • End to End Life Cycle Management
  • Professional Technical Writer
  • Process & Equipment validations - MVP, FAT, SAT, IQ, DOE, OQ, TMV, PQ, PV, Software Validations
  • High Sense of Accountability
  • Good Communication / Presentation Skill
  • Fast Troubleshooting and Problem Solution
  • Professional English (Advance Level)
  • Microsoft Office Pack
  • Microsoft Project - PMP
  • CAD/Solidworks
  • CAPA/Minitab/Data Analytics
  • 21 CFR Part 820 and ISO 13485 standars

Certification

  • Hands on PMP Examination (40 hrs), BProject
  • PMP Certification (Exam Scheduled), PMI
  • SCRUM / Servant Leadership, Jabil Healthcare
  • Lean Bronze Certification, Jabil Healthcare
  • Cell Operation System (MOS/COS)
  • Problem Solving - A3 DMAIC, Medtronic
  • Lean Leader / Green Belt Certified, Covidien
  • CAPA (Corrective Actions & Preventive Actions), Covidien
  • DOE Design of Experiment, Insydex, Certified
  • Statistical Process Control, Covidien
  • 8’D Methodology, Covidien
  • Fundamentals of Project Management, Covidien
  • Q.S.R. Quality Regulatory Systems, Covidien
  • Process Validation IQ,OQ,PQ,PV, TMV, Software Validations, Insydex
  • Industrial Ergonomic Course, Humantech
  • Liderazgo Situacional, Ibero, Trained
  • Finance/Production Cost/Budget/Capital Request-CER., Medtronic
  • English at Global English at Interlingua School., Interlingua, Advance

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Edgardo Arce Sr. PM Engineer / SCRUM Leader / OpEx