AIMEE FLORES
Los Angeles,CA
Summary
Experienced leader with strong background in guiding teams, managing complex projects, and achieving strategic objectives. Excels in developing efficient processes, ensuring high standards, and aligning efforts with organizational goals. Known for collaborative approach and commitment to excellence.
Overview
10
10
years of professional experience
Work History
Senior Engineer
Amgen, Inc.
11.2020 - Current
- Technical Team Lead for 2 combination product development programs (Class II medical device & drug product) and responsible for managing 4 clinical study and 2 commercial launch timelines
- Providing guidance to and collecting input from 2 teams of 15-20 engineers to advance programs, which has resulted in 2 successful clinical study launches
- Facilitate discussions to work through ambiguity and determine solutions in collaboration with cross-functional teams to clear program challenges and to mitigate future issues
- Authored, reviewed, and data-verified regulatory filings for data integrity and quality system compliance that resulted in successful acceptance by FDA
- Change owner for revised user needs requirements and design input requirements per updated external standards for combination product development program
- Provided SME input to Quality Plan Design Control Core Team for 5 design control SOPs and 4 design control templates
- Served as lead device engineer responsible for overseeing Class II medical device for combination product from development to clinical launch within 10 months
- Supported risk management procedures and risk management files update by data verifying system and utilizing risk assessments for 9 combination products
Senior Engineer
Edwards Lifesciences Corporation
02.2020 - 11.2020
- Provided manufacturing engineering support to international external partners to ensure selection, design, and development of manufacturing processes, equipment, and tooling for Class III tricuspid transcatheter valve repair system met business procedures, ISO 13485, and regulatory requirements
- Successfully led summarization and collation of 28 external supplier manufacturing processes for reflowed, extruded, injection molded, and machined components to be used in regulatory reporting and biocompatibility test planning
- Collaborated with suppliers to resolve component-related and manufacturing line issues to ensure highest quality product was maintained and supplier development deliverables were met.
Product Engineer
Medtronic
09.2018 - 02.2020
- Executed 8 equipment and process validations for cell operating system in ISO Class 8 cleanroom for manufacturing Class III continuous glucose monitoring (CGM) medical device, which included, but is not limited to: IQ, OQ, PQ, TMV, and CV
- Consulted and collaborated with internal manufacturing SMEs to develop process and equipment assembly procedures, manufacturing work instructions, and inspection methods to support process validation builds for CGM sensor fabrication
- Determined acceptance criteria and developed test methods for visual inspection processes for CGM sensor component defects
- Supported Receiving Inspection (RI) team for First Article Inspection (FAI) of next generation CGM device components by coordinating drawing/print revisions and Material Review Board (MRB) team by performing root cause analysis and dispositioning non-conforming components.
Engineer
Amgen, Inc.
03.2017 - 08.2018
- Successfully led 10+ interdisciplinary team members internal and external to organization to upgrade capital equipment to support packaging component development and reduce developmental timelines by estimated 3-6 months
- Developed design and qualification strategies for next generation closure label to reduce production costs, resolve functionality issues, and improve patient experience
- Supported External Supply Management team by assisting in design and implementation of digital printing processes and equipment to phase out conventional printing technologies and reduce printing cycle time from 6-8 weeks to 3 weeks
- Performed process characterizations and supported technology transfer for labeling assembly process at cryogenic temperatures for a first-in-class oncolytic virus therapy.
Associate Engineer
Amgen, Inc.
02.2015 - 03.2017
- Led and supported qualification and design verification activities to qualify the use of packaging materials and components for clinical and commercial combination product configurations per ASTM and ISO standards
- Executed feasibility studies, process characterizations, and factory acceptance testing (FAT) to support process development of packaging assembly processes at cryogenic temperatures for a first-in-class oncolytic virus therapy
- Supported remediation of packaging qualification deficiencies for seven combination products per ASTM and ISO standards.
Education
M.S. - Biotechnology And Bioinformatics
California State University Channel Islands
Camarillo, CA05.2015
B.S. - Chemical Engineering
University of California, Santa Barbara
Santa Barbara, CA06.2012
Skills
- Team Leadership
- Design Verification
- Deadline Management
- Work Prioritization
- Leadership skills
- Project Management
- Cross-Functional Collaboration
- Team Management
- Product Development
Timeline
Senior Engineer
Amgen, Inc.
11.2020 - Current
Senior Engineer
Edwards Lifesciences Corporation
02.2020 - 11.2020
Product Engineer
Medtronic
09.2018 - 02.2020
Engineer
Amgen, Inc.
03.2017 - 08.2018
Associate Engineer
Amgen, Inc.
02.2015 - 03.2017
M.S. - Biotechnology And Bioinformatics
California State University Channel Islands
B.S. - Chemical Engineering
University of California, Santa Barbara
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