OBJECTIVE

To obtain a senior/project engineer position with a leading healthcare company, with an opportunity to lead development team to develop new products that will positively impact both the healthcare industry as well as the corporation.

SUMMARY OF QUALIFICATIONS

Experienced R D Engineer with 6 years of highly technical and cross-functional work experience. In-depth knowledge of new product development, statistical analysis and regulatory compliance for Class II III medical devices. Recognized for developing innovative product ideas into new products to improve quality of life. Results driven diplomatic professional able to work effectively in teams or independently to meet and exceed business needs.

CORE COMPENTENCIES

• New Product Development
• Project Planning
• Design Controls
• Mechanical Design
• Experimental Design
• Regulatory Compliance
• Customer Interaction
• Statistical Analysis
• Process Optimization

MEDICAL DEVICE INDUSTRY EXPERIENCE

Confidential

R D Engineer I/II Peripheral Intervention division

• Currently managing/leading a team of engineer's as the technical lead to improve performance of an existing product line.
• Led multiple recertification and sustaining projects for microcatheters and embolic coils.
• Supported launch of Interlock-35 metal based embolization coil PDP from start to finish incremental revenue of 8MM
• Led development and designing of the implant and part of delivery system.
• Effectively completed of Design freeze and Design verification overcoming multiple challenges with a multi-site team and vendors.
• Managed relationship with multiple vendors for RFQs, prototype development and component delivery.
• Coordinated and managed all DV and PPQ testing to ensure an on time completion to support FDA submission.
• Worked cross-functionally with project management, manufacturing, regulatory, quality, packaging, sterilization, bio OPS to ensure that all technical documentation including drawings, drawing tree, DCMs and tolerance analysis BOMs and specifications are generated in compliance and are completed on time.
• Supported next gen. microcatheter metal based PDP by leading designing of multiple components and acute animal studies.
• Led development and designing of robust high torque sleeve and liner.
• Wrote protocols for experimentation and design freeze and coordinated testing and execution of DF testing.
• Led and designed multiple animal studies to evaluate prototypes and competitive products and understand its clinical impact.
• Provided technical support for test method and coatings development to successfully completion next generation microcatheter TDP.
• Managed a R D engineer direct reports and technician co-op indirect in design and development, including: Solidwork modeling drawings, prototype development, engineering analysis development testing.
• Managed and coordinated successfully completion of MRI testing and DFU labeling of multiple products with support of external vendors and experts. Led responding deficiency's to FDA for successful clearance of special 510 k 's.
• Assisted Regulatory Affairs with the preparation of 510 k 's and CE Marking Applications.
• Supported New Business development team in evaluating companies and it's technologies for potential acquisition.
• Supported marketing and sales reps. by visiting hospitals and customers, and performing competitive product evaluations.
• Led brainstorming sessions to generate innovative ideas for projects in cadence and performed pugh analysis to determine feasibility for those concepts. Resulted in multiple IP submissions and 5 patent submissions.
• Completed Six Sigma Green Belt and PMP training.

Confidentia

Temp. Engineer Exploratory/Orthobiologics

Lead of new product and process development and implementation projects. Designed preliminary product improvements.

• Developed platform technology for collagen and collagen-TCP based materials for neurosurgical and orthopedic procedures. Developed ultra-thin high strength collagen-silk based films for neurosurgical applications.
• Designed and performed experiments to enhance mechanical properties of collagen matrixes using different cross-linking agents.
• Performed design verifications and validations for line extension projects.
• Designed and developed manufacturing equipment by directly working with vendors and provided 3D-models, drawings for dies/tools and prototypes, using Solidworks.

Associate Product Development Engineer

• Supported the complete product development cycle of three new medical devices and their domestic and international product launches, resulting in new product line and organic growth of 5MM annually.
• Developed osteoconductive containment matrix to control migration of TCP particulates from implantation site and provide better diffusion of blood within the bone graft and effectively allows for quicker regeneration of normal bone tissue after spinal surgeries.
• Assisted in development activities from approved concept phase through launch, following Design Control Procedures including laboratory work for prototyping, testing, designing animal study, scale-up and data analysis.
• Initiated exploratory projects to enhance bone regeneration rate using Bioactive Glass and ceramic to develop osteoconductive and osteoinductive scaffolds.
• Honorable mention for the RICHARD CARUSO Innovation Award.

Confidential

Engineering Intern

• Worked under Engineering Manager to support design changes assure that the changes comply with Design Control requirements.
• Tested and validated asthma drug delivery products such as peak flow meters, spacers and ultrasonic nebulizers.
• Responsible for writing key design documentation including design verification and engineering protocols.

OTHER EXPERIENCE

Confidential

Teaching Assistant/Technical Assistant

• Teach students the fundamentals of physics and its applications in industry. Correct quizzes and exams.Physics Math Tutor for EOP students.
• Developed and maintained the web page for ESL Department. Provide technical support student for any software problems.

SKILLS

Instruments and Analytical Lyophilizers, Centrifuge, Carver Press, Vacuum Oven, Optical Microscopy, SEM, pH meter, conductive meter, BCA Protein Assay, UV Spec., Dynamic Flow Meter, Particle size analyzer, Instron, FTIR, DSC and rheometer Engineering Applications Solid Works, SW Microslot, Pro Engineer, Auto CAD, Matlab, Minitab, Simulink, Labview Training Lyophilization Technology, Design for Six Sigma: DOE, Hand-on-statistics, Process capability analysis, Measurement system analysis, SSGB, Project Management Professional PMP

PROJECTS/PRESENTATION

• Coating of Boronized Titanium alloy with Hydroxyapatite Type-I Collagen Research Project
• Hip implantation and its interaction with bone cement composites: PMMA PPF Literature Review