Erin E. Donnelly
Vienna,9
Summary
Experienced with leading multidisciplinary engineering teams to achieve project goals. Utilizes strategic planning and effective communication to streamline operations and drive innovation. Track record of implementing process improvements and fostering collaborative work environment.
Seeking a management or engineering role in Vienna (or remote in Europe/US) with an employer that supports German language acquisition or operates in an English-friendly environment.
Overview
10
10
years of professional experience
Work History
Senior Manager
Warmilu LLC
06.2023 - Current
- Optimized production workflow to 3x production capacity of infant warming heat packs with only existing equipment.
- Managed over 20 interns, contractors, and volunteers to support various initiatives and production needs.
- Planned and managed a major scale up of our manufacturing processes including sourcing new equipment and material suppliers, planning manufacturing workflows, and mapping out critical pathways in our current production process.
- Manufactured several hundred warming packs. Packed and shipped numerous orders for US and international customers. Performed regular maintenance and repairs to the manufacturing critical radiofrequency welders.
- Conducted quality assurance testing to validate new heat pack material suppliers and updated manufacturing processes to adjust for material differences to maintain Warmilu quality standards.
CEO and Co-Founder
NeoNest Global
09.2022 - Current
- Lead NeoNest Global, a 501(c)(3) nonprofit organization, in developing an accessible, non-electricity dependent neonatal transport incubator tailored for low-resource hospitals with collaborators in Ghana, Kenya, Uganda, and Honduras.
- Lead a team of over 30 engineers, interns, and student volunteers to develop and test a Class II medical device and quality system that follows ISO 13485, ISO 14971, ISO 9001, and IEC 60601-2-20 standards.
- Raised $75,000+ in grant funding to support business expenses, engineering development, and clinical trials.
- Conducted or oversaw need assessment trips to Ghana, Kenya, and Honduras with early incubator prototypes to get direct feedback from doctors, nurses, EMTs, and engineers on NICU operations and needs, design requirements, and device feedback.
Engineer I
Terumo Cardiovascular Group
Ann Arbor, Michigan
04.2020 - 08.2022
- Developed over 1000 pages of software and hardware verification protocols for the current and next generation Heart Lung Machine spanning hundreds of critical design requirements that were successfully submitted for FDA 510K approval of the next generation Heart Lung Machine.
- Lead a team of 3 engineers over 9 months in hemolysis blood testing completing a parallel analysis comparing the performance of the new and current Roller Pump designs.
- Chair of the Women’s Initiative Network (WIN)
- Directed WIN, an organization focused on advocating for gender equality in engineering. Grew the organization from 3 members to over 25 members in 6 months and increased events from 3 times a year to 28 times a year.
- Created 10+ recurring company-wide events to improve employee mental health, support women lead mentorship, encourage socialization across departments, and provide employee lead continuing education opportunities.
- Successfully lobbied for and set up a Mothers Nursing Room in my engineering facility.
Graduate Research Assistant
EMBiR – Evolution and Motion of Biology and Robotics
08.2023 - 12.2023
- Collaborated with graduate students on simulation research of the tail mechanics of the jerboa, a small desert mouse.
- Defined tail mechanics through force testing (spring loading, transducer sensors) and x-ray analysis.
- Created testing protocols and fixtures; collected and analyzed force data to enhance large-scale simulation models.
Graduate Research Assistant
Biomedical Manufacturing and Design Lab
10.2022 - 06.2023
- Researched and developed novel thrombectomy device designs/applications for treating CTEPH
- Created comprehensive in vitro testing protocols for device verification and validation
- Collaborated with University of Michigan Medicine physicians on clinical integration through procedure observation and joint R&D
English Teacher
ECC Foreign Language Institute
Osaka, Japan
11.2018 - 09.2019
- Taught engaging English lessons to students of all ages and ability levels. Utilized effective communication skills and leadership skills for efficient classroom management in both large classes and private lessons.
R&D Engineering Co-Op
Ethicon Endo-surgery, Inc.
05.2017 - 08.2017
- Utilized rapid prototyping, CAD, and 3D printing to design custom testing fixtures and procedures for tissue testing, tensile strength analysis, and device failure analysis of harmonic and robotic devices.
- Developed a test protocol that saved the team $40,000, designed fixtures, analyzed data, and assisted with product development and experiments to characterize medical device components and validate design quality requirements.
- Robotics Franchise: Front End Energy
R&D Engineering Co-Op
Ethicon Endo-surgery, Inc.
08.2016 - 12.2016
- Utilized rapid prototyping, CAD, and 3D printing to design custom testing fixtures and procedures for tissue testing, tensile strength analysis, and device failure analysis of harmonic and robotic devices.
- Developed a test protocol that saved the team $40,000, designed fixtures, analyzed data, and assisted with product development and experiments to characterize medical device components and validate design quality requirements.
- Endo-mechanical Franchise
Education
M.S. - Mechanical Engineering
University of Michigan
Ann Arbor, Michigan05.2024
B.S. - Biomedical Engineering, Biology
The Ohio State University
Columbus, Ohio05.2018
Skills
- Engineering & Design: Computer-Aided Design (CAD), SolidWorks (Certified Associate), Rapid Prototyping, 3D Printing, Design for Manufacturing (DFM), MATLAB, V&V (Verification & Validation), In Vitro Testing, Machining
- Medical Device Design: ISO 13485, Quality Systems, Design History Files (DHF), Risk Management
- Leadership & Management: Team Leadership (30 members), Project Management, Cross-functional Collaboration, Grant Writing & Fundraising ($75k), Strategic Planning, Operations Management, Process Optimization, Nonprofit Management (501(c)(3)), Mentorship
- Languages: English (Fluent), German (Beginner), Spanish (Beginner), Japanese (Beginner)
Language Skills
Fluent: English
German, Spanish, Japanese
Elementary
Timeline
Graduate Research Assistant
EMBiR – Evolution and Motion of Biology and Robotics
08.2023 - 12.2023
Senior Manager
Warmilu LLC
06.2023 - Current
Graduate Research Assistant
Biomedical Manufacturing and Design Lab
10.2022 - 06.2023
CEO and Co-Founder
NeoNest Global
09.2022 - Current
Engineer I
Terumo Cardiovascular Group
04.2020 - 08.2022
English Teacher
ECC Foreign Language Institute
11.2018 - 09.2019
R&D Engineering Co-Op
Ethicon Endo-surgery, Inc.
05.2017 - 08.2017
R&D Engineering Co-Op
Ethicon Endo-surgery, Inc.
08.2016 - 12.2016
B.S. - Biomedical Engineering, Biology
The Ohio State University
M.S. - Mechanical Engineering
University of Michigan
HONORS AND ACTIVITIES
M-HEAL – The Initiative: Neonatal Incubators – Team Lead: University of Michigan Sept 2022 – May 2024, Successfully prototyped a low-cost neonatal incubator in partnership with our community partner in Kumasi, Ghana to develop an effective and safe bassinet and heating pad to provide critical thermoregulation to low birthweight neonates.
Entrepreneurs Leadership Program (ELP) 2023 Cohort Fellow: University of Michigan Jan 2023– Jan 2024, Selected as one of 30 out of 300 applicants for a competitive cohort focused on advanced entrepreneurial training. Developed functional, managerial, and leadership skills through a rigorous experiential curriculum. Received mentorship to build a foundation for entrepreneurial success during and after college.
Hobbies
Running, Yoga, Woodworking, Knitting, Painting, Gardening, Reading