SUMMARY OF QUALIFICATIONS:
- Over 10 years of work experience as a Mechanical / Manufacturing Engineer including four years in process validation and process improvement for medical devices manufacturing.
- Experience providing a high level of technical support in an ISO 9001 manufacturing facility while working within a cross-functional team to deliver quality products within tight schedule and budget constraints.
- Solid background in model development and design validation for mechanical assemblies.
- Skilled in project management, quality control and (GD&T); good computer skills, including Finite Element Analysis, AutoCAD, Pro/E, MATLAB, Fortran and Microsoft Office.
- Active U.S. government clearance.
EDUCATION:
University of Colorado 2001
Master of Science degree, Mechanical Engineering
University of Colorado 1997
Bachelor of Science degree, Mechanical Engineering, Minor in Mathematics
PROFESSIONAL EXPERIENCE:
GE Heathcare, Laurel, MD 2013 - Present
Manufacturing Engineer (Contractor)
Provided manufacturing technical support of mechanical and electrical assembly processes for maternal-infant care medical device products. Incorporating Lean Manufacturing and Continuous Improvement technique to improve efficiency of assembly processes while reducing cost and product defects. Responsibilities included keeping production procedures and processes current and validated, addressing nonconformance and quality issues
- Created applicable, detailed work instructions and manufacturing process documents that ensure safe and successful execution of the manufacturing cycle.
- Diagnosed root cause analysis for components failure and initiated corrective actions relative to the assembly process through the use of engineering drawings and assembly specs.
- Perform failure analysis on range of components and subassemblies to identify manufacturing quality-related deficiencies and ensure parts are meeting all specific criteria.
- Initiate Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs) with supporting documentation and implementation to ensure compliance to quality assurance standards (IQ/OQ/PQ).
- Defined and implemented process validation protocols and data collection plans (DCPs) to improve and/or revalidate existing manufacturing processes in compliance with GMP and FDA's regulations.
U.S. Army Research Laboratory, Aberdeen, MD 2005 - 2013
Mechanical R&D Tech
Prepared and executed performance assessment tests on multiple ground combat vehicle systems and their components. Developed testing criteria requirements and utilized analytical methods and engineering tools (e.g. finite element modeling, AutoCAD, MATLAB, Excel, etc) to provide analyses on various mechanical system components.
- Supervised vehicle systems performance testing activities which included development of simulation models, structural and stress analysis; and documentation of test procedures.
- Performed ballistic analysis for mechanical components failure, used stat...
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