Frida Duran
Summary
Professional Project Management Specialist with experience working with multi-disciplinary teams to achieve long-term project goals. Highly proficient in NPI of Medical Devices.
Industrial Engineer, immersed in a Project Management environment of different types of projects: NPI, transfers, regulatory compliance, an improvement on manufacturing processes, labeling updates, new materials introduction and updates cross-company looking to expand knowledge in PM, finance, engineering and supply chain.
Overview
5
5
years of professional experience
Work History
Project Engineer II
Fisher & Paykel Healthcare
06.2020 - Current
- Planned, designed, and scheduled phases for large product transfer projects between facilities
- New product introduction strategies for the following processes: molding (polypropilene, silicone and overmoulding processes) , subassemblies (ultrasonic welders, laser print, semiautomatic and manual processes) and final assembly (Semiautomatic and manual assembly lines)
- Use of Smartsheet to track project progress and critical path control
- Identified plans and resources required to meet project goals and objectives.
- Follow up on schedule attainment with extended teams cross company and facilities.
- Scheduled & assigned priorities as required to move forward and meet critical project milestones.
- Monitored project performance to identify areas of improvement and make adjustments.
- Coordinated with cross-functional teams such as product development, process development and operations engineering to achieve correct knowledge transfer to the core team.
- Creation of Project Development Plans, Business Cases, Master Validation Plans and Design Transfer Controls.
- Provided detailed project status updates to stakeholders and executive management.
- Developed and initiated projects, managed costs, and monitored performance.
- Monitored project progress, identified risks and took corrective action as needed.
- Maintained open communication by presenting regular updates on project status to stakeholders
- Tracked project and team member performance closely to quickly intervene in potential risks or delays.
Validation Engineer
Fisher & Paykel Healthcare
06.2019 - 08.2020
- Developed validation master plans, process flow diagrams and standard operating procedures.
- Authored validation protocols, verifying compliance with internal policies and external safety requirements.
- Documented end to end validation processes.
- Met tight deadlines to satisfy client demands and project timelines.
- Worked with stakeholders and team members on quality assurance efforts for hardware components.
- Monitored and reported on test results and performance data to identify areas of opportunity for improvement.
- Produced and maintained technical documentation for project reference.
- Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity and other factors.
- Collaborated with cross-functional teams for identification and resolution of validation issues.
Education
Diplomate - Finance
Cetys Universidad
04.2023
Certificate - Green Belt
Academia Lean Six Sigma
06.2022
Bachelor of Engineering - Industrial Engineering
Instituto Tecnologico De Tijuana
Tijuana B.C06.2020
Skills
- Leadership
- Analytical Thinking
- Highly Effective Communication
- Budgeting
- Adaptability
- Rapid response to priorities
- Project Management Proficiency
- Process Validation
- New Products Introduction
- Risk Management
- Resource Allocation & Time Management
- Complex Problem-Solving Capabilities
- Regulatory Compliance
Languages
English
Full Professional
Timeline
Project Engineer II
Fisher & Paykel Healthcare
06.2020 - Current
Validation Engineer
Fisher & Paykel Healthcare
06.2019 - 08.2020
Diplomate - Finance
Cetys Universidad
Certificate - Green Belt
Academia Lean Six Sigma
Bachelor of Engineering - Industrial Engineering
Instituto Tecnologico De Tijuana
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