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Project Engineer, Biomedical Engineer

Location:
Greenville, NC
Posted:
March 31, 2019

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Resume:

SUMMARY

Ambitious and determined engineer with *+ years regulated industry experience and proven abilities in project management, product development, multitasking, design, prototyping, and analytical problem solving. Professional and dedicated leader. Completed 20+ capital projects in a regulated manufacturing industry. Passion for medical device industry.

EDUCATION

North Carolina State University, Raleigh, NC May 2016

M.S. Mechanical Engineering GPA: 3.8

East Carolina University, Greenville, NC May 2015

B.S. Engineering, Biomedical Concentration Major GPA: 4.0

B.S. Biology Major GPA: 3.97

Summa Cum Laude, Honors College Graduate

EXPERIENCE

Engineer III / Project Engineer, 10/2018 – Present

Engineer II / Project Engineer, 08/2016 – 10/2018

Thermo Fisher Scientific / Patheon Manufacturing Services, Greenville, NC

Manage up to $5M capital engineering projects with coordination of internal and external technical groups and become a SME on processes/equipment in a cGMP aseptic pharmaceutical manufacturing industry.

Develop and implement solutions through design criteria, functional specifications, user requirements, and drawing updates devoted to problem solving, equipment R&D, prototyping, and process optimization.

Execute process engineering support, design experiments, manufacturing process assessments, writing procedures, and deviation root-cause analysis to improve quality, yields, cycle time, cost, and risk reduction.

Oversee and assist in all project phases, including equipment installation and qualification, construction, contractor oversight, safety verification, training, operations, calibrations, automation, and validation efforts.

Lead manufacturing projects by collaborating with customers and vendors, providing technical support, researching equipment/processes to meet VOC specifications, and managing schedules, capital budgets, and resources.

Maintaining industry standards and regulations set by FDA, EMA, etc. through equipment and utility design, updating facility and process drawings, creating SOPs, and providing engineering support for site audits.

Design Capstone Project Engineer, 08/2014 – 06/2015

ECU Engineering / School of Dental Medicine, Greenville, NC

Invented a dental procedure simulation educational device to be used within the dental school curriculum.

Achieved new medical device product launch and development through collaboration with an engineering team and company sponsor by applying design process, technical research, and project management.

Designed SolidWorks 3D solid-modeling and 3D-printed prototypes from alternate innovation ideas addressing VOC and intended for patent and commercialization.

Assessed feasibility of design ideas based on requirement criteria, criticality analysis, and prototype functionality testing; compared to existing methodology and market to apply process optimization.

Project Management Intern, 06/2014 – 08/2014

Patheon Manufacturing Services, Greenville, NC

Participated in pharmaceutical industry projects and presented recommendations on company weaknesses and improvements.

Contributed to customer project critical tasks including data analysis, equipment calibration, determining reconciliation limits, writing technical reports, project meetings, organizing inventory lists, and SOPs.

Research for Biomedical Engineering, 02/2013 – 06/2014

ECU Engineering / Brody School of Medicine, Greenville, NC

Designed a biomedical engineering research project through studying current literature, creating an experimental protocol, and writing a proposal to receive grant funding.

Researched and tested electrospinning methods and parameters through experimentation and nano-fiber analysis using biotechnology equipment and laboratory techniques.

Conducted statistical analysis on lab experimentation and data collection of electrospinning post-processing techniques and stem cell interaction, applying regression modeling and significance testing.

Lead Engineering Tutor, 08/2012 – 05/2015

ECU Pirate Tutoring Center, Greenville, NC

Headed tutoring efforts for engineering curriculum, training peer tutors, and provide supervision during tutoring sessions.

Cardiac Surgery Intern, 06/2012 – 08/2012

East Carolina Heart Institute, Greenville, NC

Collaborated with doctors to conduct medical care research, analyze case studies, practice surgical and dissection techniques on cadavers and animal anatomy, and assist in robotic surgical training courses.

Shadowed cardiovascular surgeries, vascular clinics, cardiology clinics, catheterization labs, robotic training labs, and other departments of the healthcare system.

Studied in-process use of medical devices, including the da Vinci Robotic Surgical System, catheters, imaging, and endoscopy.

TECHNICAL SKILLS

Project Management

Product Design

Leading cross-functional teams

Research and Development

Rapid Prototyping

Resource Allocation

Budget Management

Customer/Vendor Communication

3D Printing

Aseptic Processing Certification I & II

Construction

Troubleshooting

Woodworking

COMPUTER SKILLS

Microsoft Excel

Microsoft Project

Microsoft Visio

SolidWorks

AutoCAD

MATLAB

LabView

BASIC Stamp



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