Summary
Overview
Work History
Education
Skills
Accomplishments
Affiliations
Additional Information
Software
Certification
Timeline
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Mario Arias Cedeño

Mario Arias Cedeño

Biomedical Engineer
Flores, Heredia

Summary

Resourceful Project Manager with 20+ years of expertise in organizing business operations, financial oversight and resource management to achieve smooth flow and project operations. Leads procurement of resources including equipment and supplies. Monitors projects by adhering to production schedule and budget, managing production team, identifying problems and providing targeted solutions. Knowledgeable in accounting principles, bookkeeping, budget and financial management.

Overview

21
21
years of professional experience
6
6
years of post-secondary education
3
3
Certifications
3
3

Language3

Work History

Quality Manager, Product Manager, Project Manager

  • Coordinated with relevant stakeholders, internally and externally, to ensure the project proceeds according to the plan, meeting project's goals & objectives
  • Worked with Project Management Office to refine approach, sharing learnings and best practices
  • Tracked and reported on key metrics to customer
  • Sustaining of a class II operation as QA and R&D Senior Manager
  • Faced FDA inspections
  • Developed a PLM software product as per customer requirements
  • (Salesforce Admin certified)

Manufacturing / Design Engineer

  • Strengthened company's business by leading implementation of CAPAs and non-conforming material reports from customer reports and in-process incidents
  • Partnered successfully with R&D department to conduct product improvements
  • Led the first design change out of USA related to pulmonary biopsy forces, based on customer complaints reports
  • Conducted equipment and line validations (IQ, OQ, PQ)
  • Created and improved manufacturing instructions
  • Other tasks associated to a multi-disciplinary manufacturing engineer.

PRINCIPAL CONSULTANT

Boston
01.2017 - Current

Senior Consultant and PM, CRx Lifesciences

REFERENCES, Juan C. Ballestero, Cardinal Health
01.2017 - Current
  • Determined areas for improvement and implemented processes to alleviate problems.
  • Analyzed problematic areas to provide recommendations and solutions.
  • Identified key areas in need of improvement and implemented plans to rectify issues.
  • Monitored and managed staff performance to attain target metrics both individually and team unit.

Project Manager

ABBOTT VASCULAR
Alajuela
01.2011 - 01.2017
  • Worked directly with inter-divisional departments to achieve the process control project / phase I
  • Set and led interdivisional meetings to implements key projects for the Costa Rica facility
  • Trained, coached and mentored staff to ensure smooth adoption of the process control program
  • Implemented innovative programs to increase clinical education in the Costa Rica facility in partnership with sales training department
  • Identified and implemented cost reduction projects in the subassembly area of drug eluted stents delivery systems
  • Cleanrooms (Class 7 and 8) and process validation
  • Voluntary Jobs

Sr. Transfer Engineering Lead

BOSTON SCIENTIFIC | Heredia
01.2005 - 01.2011
  • Transfered the guidewire manufacturing operations from Miami to Costa Rica
  • Developed the transfer plan, budeget and addered to it
  • Validation strategy definition to comply with FDA class II and class III devices
  • Developed the transfer plan, budeget and implemented the project ahead of time (conducted a process yield improvement).

Field Service Engineer

GROHMANN ENGINEERING, Prum, GE
01.2003 - 01.2005
  • Transferred, installed and qualified the IHS, Die attach and chipset assembly machines to Costa Rica
  • Reduced in 30% the failure rates of the chipsets assembly machines
  • Successfully conducted equipment troubleshooting and customer assistance when needed
  • Created machine failure indicators and maintenance plans.

Education

Master - Artificial Intelligence, Biomedical Engineering

Leasd University
01.2020 - 05.2021

Bachelor - Biomedical Engineering

Basque Country University
01.2014 - 05.2015

Biomedical Engineering

Universidad Latina
01.2001 - 05.2004

Skills

Teamworkundefined

Accomplishments

  • QSR and Industry Practice, AAMI
  • Six Sigma Black Belt, ASQ
  • Certified Quality Engineer, ASQ
  • Infinity QS, Proficient
  • Risk Management, CAIHabits of HEP, F.Covey
  • Influencer, Vital Smarts
  • Motivating other, Achieve Global
  • Corp
  • Social Responsibility, AED
  • EXPERIENCE
  • Head of Quality Control Department – Transfer Activities
  • Managed, hired, developed and recognized technical staff – two supervisor, two technicians and over fifty indirect reports
  • Implemented innovative programs to increase employee loyalty and reduce turnover, no resignations for 2.5 year
  • Directed FDA/BSI/Dekra readiness activities previous inspection to ensure site’s compliance with regulations with zero findings
  • Conducted the successful transfer and validation of the chemical mixing laboratories from California to Costa Rica.

Affiliations

Manufacturing and Quality professional with proven abilities in process improvement, project management, product transfer, medical device design. Over 15 years of experience in world class manufacturing of medical devices, electronic industries, field service and consultant services.

Additional Information

  • AWARDS , Corporate CAPA Cup Boston Scientific 2008 Safety Environment Abbot Vascular 2013

Software

Salesforce Administrator

Certification

CSSBB, from ASQ

Timeline

SAlesforce Administrator, from Trailhead

09-2022

Master - Artificial Intelligence, Biomedical Engineering

Leasd University
01.2020 - 05.2021

PRINCIPAL CONSULTANT

01.2017 - Current

Senior Consultant and PM, CRx Lifesciences

REFERENCES, Juan C. Ballestero, Cardinal Health
01.2017 - Current

Bachelor - Biomedical Engineering

Basque Country University
01.2014 - 05.2015

CSSBB, from ASQ

03-2011

Project Manager

ABBOTT VASCULAR
01.2011 - 01.2017

CQE, from ASQ

12-2006

Sr. Transfer Engineering Lead

BOSTON SCIENTIFIC | Heredia
01.2005 - 01.2011

Field Service Engineer

GROHMANN ENGINEERING, Prum, GE
01.2003 - 01.2005

Biomedical Engineering

Universidad Latina
01.2001 - 05.2004

Quality Manager, Product Manager, Project Manager

Manufacturing / Design Engineer

Mario Arias CedeñoBiomedical Engineer