TECHNICAL SKILLS

Computer: Microsoft Office, Excel, PowerPoint, Database Research, Creo Parametric, ANSYS, Mechanical APDL, SOLIDWORKS, Pro/ENGINEER, LabVIEW, MATLAB, Troubleshooting, Computer Aided Design, Mechanical Testing, Finite Element Analysis.

Medical: Advanced Design Modification, Design Controls, Validation, Verification, Project Management, FDA Regulations, ISO, Class I, II, III, 510K knowledge, GLP, GMP, GCP, Device Development, Risk Management, Problem Solving, Mathematical Analysis, and Statistical Data Analysis.

Others: Interpersonal, Leadership, Management, Detail orientated, Organizational skills, Time Management, Cross - functional teams, and Customer Service.

PROFESSIONAL EXPERIENCE

Confidential, Somerset, NJ

Engineering Co-op

Responsibilities:

• Responsible for ensuring established manufacturing processes are efficient and cost effective, as well as developing improvements to products and processes
• Develop preventative maintenance plans.
• Conduct FMEA, DOE, and SPC analysis and use other quality tools to fulfill customer requirements and manufacturing initiatives
• Provide technical guidance and direction for manufacturing
• Provide input to the production controls system and design controls activities
• Enable quality initiatives as they relate to the customer, corporate objectives, quality planning, the quality policy, process improvement and new business goals and objectives. Communicate with customers, suppliers and other resources in order to achieve these objectives
• Participate in research and development activities in terms of process implementation and validation of processes / products, process improvement and metrics
• Provide input for new product equipment selection, installation and maintenance
• Write detailed work instruction-level documents for manufacturing operations and related areas. Summarily train personnel in these instructions and other technical process controls
• Conduct engineering studies and analyze data
• Map work flow(s) and develop process control plans
• Develop and conduct cost reduction and quality improvement projects
• Develop and submit validation packages for customer approval of new parts, design modifications and / or process changes
• Troubleshoot manufacturing equipment and processes
• Field customer complaints, determine root cause and develop corrective actions
• Quarantine, document and disposition product and materials
• Develop and evaluate inspection methods and measurement capabilities
• Map work flows and identify non-value-added activities
• Evaluate process stability and capability
• Provide input to the Advanced Product Quality Planning (APQP) process in the development of new jobs

Confidential

ELA Director

Responsibilities:

• Designed and coordinated recruitment, training, rules and regulations of the team members
• Provided direct supervision for the staff and worked both independently and within a team
• Provided individual and group counseling for program participants and assure program standards are followed
• Analyze, organize, and present data in a clear manner to predict performance of program participants and generate comparative analysis report
• Assisted in monitoring the budget, tracking budget, and work schedules
• Worked closely with internal departments through interpersonal skills, communication, and presentations, to resolve on campus issues as well as events that take place off site
• Continuously participate in workshops and seminars for designing new methods and strategies to further develop and improve the program and increase results

Confidential, Newark, NJ

Medical Device Development Research Assistant

Responsibilities:

• PEG Feeding Tube System, a new medical device, was examined through different departments of the medical industry such as Research of current market, Engineering components of the device, Regulatory pathway, Clinical trials, Quality, and Market by generating a proposal for submission.
• Bottle Label Development for a Hydrophilic Coating Product- followed the given verification tests and tested labels for adhesion to glass while submerged in water. Developed new test methods, re-wrote protocols for a new verification test after examining the test conditions and product components given.
• Injectable Bone Growth Factor Syringes- Proposed a new way of configuring the growth factor with the syringes with 2 years of shelf life according to DSD. Conceived and tested an alternative method to store and deliver the growth factor from syringes, and quickly by changed in the carrier, liquid solvent, and syringe system, anything except the growth factor itself. Proposed easy preliminary tests to test against the specifications and requirements.
• Correcting Deficiencies in a Quality System- qualified a second source for the thread material used to create the company’s artificial ligament product. Using the GMP guidelines, a Document Change Request (DCR) was submitted to a company in Quality that created a Revision B of this SPEC, which happens to have the designation SPEC-1234. Knowledge of SOPs, GMP, and other regulations was studied before submitting this DCR.

Confidential, Newark, NJ

Finite Element Analysis Research Assistant

Responsibilities:

• Created a femoral hip stem implant using Creo Parametric and imported to ANSYS for analysis. Stem was fixed at the bottom and subjected to several diagonal axial loadings on the head socket. Static structural analysis was performed on this model to test for stress concentration. Tension, Compression, and Torsion testing were performed to evaluate the femoral hip stem implant designed. Used titanium, cobalt, steel to analyze the differences in stress concentrations on the stem as the material was changed; functional testing was performed in order to make marketable femoral hip stem implant.
• Created a femur model using SOLIDWORKS and imported to ANSYS for analysis. It was constrained at one end and torsional, compressive, combined forces were applied on the opposite end. Static structural analysis was performed on the model and results were compared to a simple version of the model to test for accuracy. Tension, compression and torsional testing were performed to evaluate stresses.
• Designed an Allen Wrench in ANSYS and several loads were applied on it. A static structural analysis was performed to find the maximum stress and strain. These results were then compared to analytical solutions. Tension, Compression, and Torsion testing was done to test the model for different stresses.
• Used shell elements to design a bone fixing plate in ANSYS. A static structural analysis, model analysis, and harmonic analysis were performed on the plate as it went under static and dynamic forces. The results of maximum stress and strain were compared to analytical calculations.
• Created a femoral component of the total knee system using Creo and converted to FEA model per Standard Test Method for Finite Element Analysis of Metallic Orthopedic Total Knee Femoral Components under Closing Conditions. Standard analysis and fatigue analysis were performed on Creo Parametric Stimulate.
• Created a 3D disk implant using Creo and SOLIDWORKS to examine the axial and flexion stiffness of the implant. Standard analysis and fatigue analysis were performed for axial, flexion, and combination of both to understand the wearing, stress, and displacement of the implant. Tested against the specifications and requirements of the implant.
• Tested on the acetabular component against specifications and requirements using Creo Stimulate with the focus on contact stress with variant orientation of components and safety margins per the ASTM standard in the static analysis.