Summary
Work History
Education
Skills
Software Applications and PLM Systems
Timeline
Generic

Sara J. Oswald

Monument,CO

Summary

Dynamic systems engineer with a proven track record in developing and integrating complex work systems across all stages of the product development lifecycle for project execution. Expertise includes collaboration with cross-functional teams within multiple R&D departments, leveraging originality and sound judgment to evaluate, and adapt projects to standard techniques and procedures. A comprehensive understanding of medical device industry precedents and principles, combined with a strong foundation in product lifecycle, facilitates effective problem-solving and innovation. Skilled in planning and executing design engineering timelines and process leadership tasks independently, ensuring alignment with company practices and policies while driving project success.

Work History

Manufacturing Project Manager

June 2025 - May 2026
  • Led implementation of product readiness and commercialization for new product configurations by ensuring seamless collaboration between outside customer contacts and Philips by providing solutions to difficult technical issues associated with the project timeline and execution.
  • Coordinated with peers across projects to secure resources and commitments while establishing timelines and phase gates for multiple projects simultaneously.
  • Communicated project updates to stakeholders and team members in order to understand how to approach and complete tasks within the project timeline, by highlighting risks to avoid serious delays and minimize backorder scenarios.
  • Facilitated collaboration among International Regulatory and product management to implement FDA and international regulatory requirements for the coordination of product global launch and new market introduction.
  • Facilitated complex technical information/analysis events with the Manufacturing, Materials and Order management teams to determine the source of material shortages for manufacturing components.

Sustaining Labeling Engineer

October 2022 - June 2025
  • Supported the post-SAP monitoring by using technical problem solving skills to generate and evaluate alternative solution concepts and architectures to labeling templates used in production.
  • Provided leadership for the Labeling group’s product development, direction, and effectiveness, adhering to organizational policies and processes while supporting overall business and corporate objectives by determining project prioritization and executions timeframes.
  • Supported the day-to-day production floor activities by assisting in equipment trouble-shooting, and the creation/modification of procedures and design specification through the use of working knowledge of cross-functional and related technical areas.
  • Undertook project leadership responsibilities for the Labeling sustaining and NPI group by creating an intake process in which projects were evaluated cooperatively and effectively within a team environment to achieve common goals and results for cross-functional teams' deadlines.
  • Advised team members on comprehensive project scoping and planning for MLD projects by proactively communicating technical ideas to promote skill development of teamwork and cross-functional participation.

EUMDR Labeling Consultant

January 2020 - October 2022
  • Initiated design and creation of new product labeling to align rebranding guidelines and cross-functional requirements with the understanding of FDA and international regulatory requirements.
  • Used testing feedback on various technical processes to enhanced label template layout logic and functionality in Enlabel Composer for improved efficiency and sustainability in the production environment.
  • Supported technical file review questions from BSI by providing responses to questions from technical staff members and management on labeling and IFU compliance to regulation requirements.
  • Executed product labeling release by strictly adhering to organizational policies and processes regarding the labeling change control procedures to obtain cross-functional approvals.
  • Led implementation of process improvements by leading collaboration with cross functional teams for the enhancement operational efficiency and anticipated customer needs.

Education

Bachelor of Science - Industrial Engineering

Texas State University
San Marcos, TX
08-2018

Skills

  • Technical leadership
  • Project Management
  • Risk management
  • Coordination with cross-functional team
  • Adaptations and modifications to projects
  • FDA and regulatory requirements implementation
  • Technical Problem Solving
  • Strong understanding of GMP practices
  • Effective written and verbal communication
  • End-to-end lifecycle management
  • Product Configuration management
  • Process optimization and improvement

Software Applications and PLM Systems

Microsoft Office | Microsoft Project | Visio | Mondy.com | Minitab | Solidworks | AutoCAD | SAP | Windchill | Agile | Catsweb | enLabel

Timeline

Manufacturing Project Manager

June 2025 - May 2026

Sustaining Labeling Engineer

October 2022 - June 2025

EUMDR Labeling Consultant

January 2020 - October 2022

Bachelor of Science - Industrial Engineering

Texas State University

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