Experience

Cadence, Inc.

• United States
• Medical Equipment Manufacturing
• 200 - 300 Employee

• New Product Introduction (NPI) Lead

  • Apr 2023 - Present



ATL Technology, LLC

• United States
• Medical Equipment Manufacturing
• 200 - 300 Employee

• Sr. Project Manager, New Product Introduction (NPI)

  • May 2022 - Mar 2023

• Technical Project Manager

  • Sep 2020 - May 2022

  • Report project status to Executive Team – schedule, budget, scope, and risks.• Work with contractors during internal expansion projects and addition of new capabilities.• Monitoring legal and environmental permits as part of internal expansion projects.• Responsible of tracking budget and expenses during expansion and construction projects.• Guide and lead the Operations team during project Process Validation Phase (PV)• Apply knowledge of ISO 13485 and 21 CFR 820 to project schedules and documentation requirements.• Direct and manage functional teams at Operations during project implementation. • Initiating, planning, monitor and controlling of execution, and closing of projects ensuring consistency with company strategy, commitments, and goals.• Ensures the project’s objectives and expectations are clearly defined, documented, and well understood• Lead local transfers (Building to Building) and global transfers (Site to Site).• Establish and maintain relationships with internal and external (contractors). Show less

• Site Project Manager

  • Dec 2018 - Sep 2020

  • Oversee project life cycle: Initiate, Plan, Execute, Monitor& Control and Close.• Perform & report on resource impact analysis based on project period of performance.• Establish and maintain relationships with internal and external customers and company stakeholders.• Responsible for clear, accurate and effective communication to all parties within project scope.• Ensures the project’s objectives and expectations are clearly defined and documented, and well understood between the customer and the company.• Maintain project plans as appropriate to meet changing needs and requirements with appropriate change process.• Responsible for scope management, coordinating team member work, identifying potential risk and managing risk (technical and business).• Leading and holding Global Team members accountable for quality and timeliness of work.• Guides project team through Phase Reviews.• Coordinate internal resources and third parties/vendors for the flawless execution of project. Show less



Theragenics Costa Rica

• Costa Rica
• Medical Device
• 1 - 100 Employee

• Sr. Project & Manufacturing Engineer

  • Apr 2018 - Dec 2018

  - Manage and coordinate the operations and technical activities of Engineering. - Analyze and assist in the formulation of overall department objectives, continuous improvement methods, cost reduction proposals, plans and programs. - Provide technical and specialized functional services to all departments - Create and execute validation protocols and reports - Provide Project Management Experience. - Manage and coordinate the operations and technical activities of Engineering. - Analyze and assist in the formulation of overall department objectives, continuous improvement methods, cost reduction proposals, plans and programs. - Provide technical and specialized functional services to all departments - Create and execute validation protocols and reports - Provide Project Management Experience.



Philips

• Netherlands
• Hospitals and Health Care
• 700 & Above Employee

• Project Engineer

  • May 2017 - Apr 2018

  - Coordinate and implement projects for current and new products and processes. - Execute the proper strategies to provide a follow-up that allow prevention/mitigation of project issues - Perform troubleshooting on new and existing products/process issues related to design, material, or process. - Provide support in Quality Investigations and ensure a successful execution of Corrective and Preventive actions (CAPAs). - Coordinate and implement projects for current and new products and processes. - Execute the proper strategies to provide a follow-up that allow prevention/mitigation of project issues - Perform troubleshooting on new and existing products/process issues related to design, material, or process. - Provide support in Quality Investigations and ensure a successful execution of Corrective and Preventive actions (CAPAs).



Hospira

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Operations Project Manager

  • Sep 2015 - May 2017

  - Supervise and provide work directions to the Project Engineers and the team involved.- Work cooperatively with Research and Development (R&D), Quality Engineering, Production, Regulatory, Supplier Quality, and Corporate Program Managers to ensure projects success and accomplish.- Lead the preparation and definition of the project scope, schedule, and the respective activities, tasks, goals and deliverables.- Responsible for leading or supporting multiple NPI (New Product Introduction) projects acting as the local contact and SPA.- Leading and/or collaborating globally in design key projects of new products, managing internal and external resources to achieve corporate objectives. Show less

• Manufacturing Process Engineer

  • Sep 2012 - Aug 2015

  - Supervise, guide and provide work directions to the direct reports (Repair and Engineering Technicians).- Provide daily support of products, process, materials, and equipment in order to achieve manufacturing goals such as quality, delivery, cost, productivity, and safety.- Perform troubleshooting on new and existing products/process issues related to design, material, or process.- Provide support in Quality Investigations and ensure a successful execution of Corrective and Preventive actions (CAPAs).- Address the disposition and closure of Non Conformance Reports related to Manufacturing process.- Monitor performance of process and equipment that produce non-conforming products, low yields or product quality issues.- Ensure that the manufacturing operators can follow and execute the steps and instructions stablished in the manucturing procedures (work instructions).- Prepare technical reports to communicate results to Management and/or cross-functional teams.- Provide support in the completion and maintenance of risk management activities, including the assessment and update of pFMEA documents.- Coordinate and work with Calibration Department to ensure and maintain all equipments within calibration parameters and regulatory requirements. Show less

• Process Engineering Technician

  • Sep 2011 - Sep 2012

  - Provide daily sustaining and technical support to the manufacturing line.- Create validations protocols such as IQs, OQs, PQs, Engineering Studies as required.- Train the manufacturing and qualty personnel in process improvements.- Ensure that the manufacturing line has the proper and required equipment to perform the assembly and testing process.- Conduct validation activities of new processes in the manufacturing line.



Teradyne

• United States
• Semiconductor Manufacturing
• 700 & Above Employee

• Electronic Test Technician

  • May 2011 - Aug 2011

  - Execute several tests to the PWA Boards to guarantee that they were 100% functional and according to all software/hardware specifications. - Repair of PWA Boards the presented issues or damages during the process. - Perform assembly steps previous to the testing process. - Execute several tests to the PWA Boards to guarantee that they were 100% functional and according to all software/hardware specifications. - Repair of PWA Boards the presented issues or damages during the process. - Perform assembly steps previous to the testing process.



Compañía Nacional de Fuerza y Luz (CNFL)

• Intern

  • Aug 2010 - Mar 2011

  Responsible of developing a Power Quality study which includes the following: - Technical criteria to ensure a proper Power Quality in Industrial and residential users. - Local and international regulations for Power Quality and Grounding. - Identify and analyze the most critical Power Quality events and how these affect the users. - Understand and identify the appropiate eletronic protections and how they mitigate the events. Responsible of developing a Power Quality study which includes the following: - Technical criteria to ensure a proper Power Quality in Industrial and residential users. - Local and international regulations for Power Quality and Grounding. - Identify and analyze the most critical Power Quality events and how these affect the users. - Understand and identify the appropiate eletronic protections and how they mitigate the events.