Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Additional training
Additional Information
Timeline
Generic
Daniela Alejandra Moreno Sarmiento

Daniela Alejandra Moreno Sarmiento

Tijuana,B.C.

Summary

Project engineer with over four years of experience in medical industry. Hard-working and self-motivated. Focused on implementing the design transfer on time, valuing mainly effective teamwork. Experience includes design assessments, design control plans, validation protocols, statistical analysis, and risk assessment for process validations & supplier changes.

Overview

4
4
years of professional experience

Work History

Project Manager II

Paykel Healthcare
09.2022 - Current

https://www.fphcare.com/us/

  • Managed projects from procurement to commission.
  • Lead planning and implementation of cross-functional projects.
  • Project tasks and resource requirements definition.
  • Project budget management.
  • Development and management of risk mitigation strategies for projects.
  • Track project deliverables using appropriate tools.
  • Implementation and management of project changes to achieve project results.
  • Facilitation of definition of project scope, objectives and deliverables for cross-functional project team.
  • Implementation and validation of regulatory changes (MDR: labels, User instructions, packaging).
  • Implementation of design transfer through each of its stages (Process inputs, process outputs, Verification and Validation).
  • Presentation of reports defining project progress, problems and solutions.
  • Quality Assurance during projects implementation.
  • Coordination to keep multiple priorities moving at the same time.

Junior Project Manager, Fisher and Paykel

Healthcare
10.2021 - 09.2022

https://www.fphcare.com/us/

  • Preparation of project development plans (Project Charters, plans and strategies, timelines).
  • Definition of project scope, deliverables, acceptance criteria, constraints, and activities necessary to meet goals.
  • Establishment of activities sequentially with their duration, estimation of required resources and development of timeline.
  • Organization and coordination of project team.
  • Communication and teamwork with international staff.
  • Elaboration and presentation of Design Reviews.
  • Engineering documentation drafting.
  • Analysis of past experiences to generate lessons learned and apply them in future projects.
  • Coordination and execution of validations: IQ, OQ, PQ.
  • Coordinated project meetings and confirmed relevant stakeholder awareness of tasks, goals and project timelines.

Engineering Intern, Fisher and Paykel

Healthcare
06.2020 - 09.2021

https://www.fphcare.com/us/

  • Development of validation protocols (IQ, OQ, PQ).
  • Coordination and execution of validation runs, engineering assessments and confirmation runs.
  • Process development and documentation: Test reports
  • Drafting of documentation.
  • SAP System (BOM, Routing, Material Release).
  • Process Capability Analysis.
  • Work with multidisciplinary groups.
  • Fulfill activities according to project schedule.
  • Collaborated with senior engineers on projects and offered insight.

Manufacturing process intern

Avanos Medical
11.2019 - 05.2020

Avanos.com/

  • Root-cause analysis.
  • Elaboration and execution of validation protocols.
  • Data analysis (Minitab).
  • Lean Manufacturing tools application.
  • Elaboration and updating of visual aids, procedures, work instructions.
  • Development and implementation of SPC.
  • Participation in KAIZEN events.
  • Exercised influence without authority and made wise decisions that improved manufacturing process.

Quality control Intern

Avanos Medical
02.2019 - 05.2019

Avanos.com/

  • Elaboration and execution of validation protocols (IQ,OQ,PQ).
  • Lay outs design.
  • Quality documentation drafting.
  • Participation in root-cause investigations for customer complaints.
  • Development and validation of new inspection methods.
  • Staff training.
  • Worked independently on assignments involving varied and complex issues without direct supervision.

Education

Bachelor's degree - Biomedical Engineer, industrial manufacturing

Instituto Tecnológico De Tijuana
Tijuana, MX
2021

Skills

SOFT SKILLS

  • Teamwork and leadership
  • Project Management
  • Active listening
  • Competitiveness and fast learner
  • Problem-Solving
  • Ability to work under pressure

HARD SKILLS

  • Office Software
  • Planning tools (Smartsheet, Clarizen, yEd)
  • Zebra Printer equipment
  • Axicon Label Verifier
  • Minitab

Accomplishments

  • Component change projects -savings, more than $ 500K USD.
  • MDR update and implementation project – 42 FG models.
  • MDR update and implementation project - 344 packaging materials
  • Implementation and validation of component specification changes – 18 molding tools
  • Capacity increase projects – 3 molding tools + 3 subassembly stations

Languages

English
Professional Working

Additional training

  • Problem Solving (DDORA Methodology).
  • Safe Start (work environment safety course).
  • Project Management (taught by PMI certified instructor).
  • Ergonomics course.
  • Human Rights Course (taught by representative of the CNDH).
  • Leadership course.

Additional Information

B1/B2 Visa Border Crossing Card

Status: In effect.

Timeline

Project Manager II

Paykel Healthcare
09.2022 - Current

Junior Project Manager, Fisher and Paykel

Healthcare
10.2021 - 09.2022

Engineering Intern, Fisher and Paykel

Healthcare
06.2020 - 09.2021

Manufacturing process intern

Avanos Medical
11.2019 - 05.2020

Quality control Intern

Avanos Medical
02.2019 - 05.2019

Bachelor's degree - Biomedical Engineer, industrial manufacturing

Instituto Tecnológico De Tijuana
Daniela Alejandra Moreno Sarmiento