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MANUFACTURING, MATERIALS, QUALITY, MECHANICAL ENGINEER

Objective: Engineer integrating manufacturing and materials knowledge with mechanical skills and quality concepts.

Professional Experience: 

Manufacturing Engineer, Consumables, Nova Biomedical, Waltham, MA    November 2014 – Present

  • Provide engineering support for Consumable Product/Sensor manufacturing
  • Plan, write, and execute Tooling/Equipment and Process Qualifications/Validations
  • Create, release, and maintain Assembly Procedures, Test Procedures, Operating Instructions, drawings, and SOPs
  • Preform NCMR and CAPA investigations
  • Collaborate with vendors to maintain and enhance sourced material quality
  • Perform design analysis and changes for released/pre-release products with R&D
  • Create, release, and maintain FDA UDI compliant labeling, insert sheets, and artworks
  • Consumables representative at company QRF meetings, Quality SOP meetings, and MasterControl implementation meetings
  • Perform internal audits
  • Act as an independent reviewer for IQ/OQ/PQ sign-off meetings
  • Hire, Manage, Supervise, and Mentor Co-Ops
  • Experience with FDA, ISO 13485, ISO 9001, PMDA, Health Canada, CE requirements

R&D Sustaining Engineer Contractor, Boston Scientific, Marlborough, MA    October 2013 – September 2014

  • CAPA and VIP experience, including gathering and analyzing data to update product manufacturing specifications
  • Designed and conducted experiments/measuring techniques and wrote technical reports
  • Created/maintained test documentation and validation throughout testing process, including test method updates and Gage R&Rs
  • Leveraged test methods, test method validations, and wrote tooling equivalencies
  • Real Time Aging testing, due diligence, and testing reports
  • Experience creating and updating official documents, including creating change request documentation
  • Laser training, Instron experience, and experience with various urological test methods, protocols, and SOPs
  • Provided training and direction to technicians and interns/co-ops and collaborated with other facilities
  • Product Experience: ureteral stents and catheters, stent positioners, nephrostomy products, guidewires

Manufacturing Engineer I, Tegra Medical, Franklin, MA        August 2012 – January 2013

  • Performed manufacturing process and materials selection experiments and investigations to improve product quality, speed, and customer service
  • RA / NCR / CAPA Investigation
  • IQ / OQ / PQ design and implementation for new and existing machines and processes
  • Designed experiments to better understand and evaluate processes to minimize downstream and customer returns
  • Attended IMTS 2012 to gather information on new cleaning technologies to update current facilities
  • ISO 9001 and 13485 and RoHS directives
  • Lean Manufacturing Implementation and Six Sigma Greenbelt training
  • GD&T and GMP
  • Internal Audits
  • Used Minitab to design DOEs and analyze manufacturing and quality data
  • Maintained wet processes (chemical deburring, acid etch, etc.) and cleaning departments by performing upgrades,  maintenance, and safety testing
  • Managed Cleanroom and performed particle count testing and cleanroom assembly
  • Profilometer surface measurements for grinding, chemical polishing, and laser abrading

Junior Engineer, GENESIS Tech Center, Tegra Medical, Franklin, MA        September 2010 – August 2012

  • Provided customer and manufacturing support for prototyping, materials selection, and surface properties
  • Created work instructions, PFMEAs, Control Charts, and other manufacturing and quality documents for new and current product manufacturing processes
  • Worked with other departments to ensure manufacturability for the transition between prototyping and large scale runs
  • Experience with laser marking and welding, CNC manufacturing, and assembly
  • Project management and management of interns
  • Performed experiments and testing with electropolishing, coatings, and adhesives
  • Profilometer surface measurements for grinding, chemical polishing, and laser abrading
  • Experience with grit blasting, lapping, and hand polishing
  • Worked with metals and plastics
  • Cleanroom assembly
  • Nitinol Processing and BFR testing
  • Design of Experiment (DOE) experience
  • IQ / OQ / PQ design and implementation
  • RA / NCR / CAPA Investigation and GD&T

 

Other Experience :

Teaching Assistant, Materials Science and Engineering, WPI        January 2009 – May 2010

  • Assisted with teaching, grading, office hours, and student discussion groups
  • Intro to Material Science and Engineering
  • Nanotechnology
  • Automotive Materials

Process Engineer Summer Intern, Supfina Machine Co., Inc., N. Kingstown, RI        May 2008 – Sept. 2008

  • Superfinishing
  • Measured micro/nano-sized surface features using contact profilometry and light microscopy
  • Quality inspections on incoming parts/materials
  • Calibrated tools
  • Ran, cleaned, and packaged parts to be used in process engineering and customer products

Office Assistant, Law Offices of Aram P. Jarret, Jr., Woonsocket, RI        May 2005 – January 2008

  • Proofread and typed legal documents
  • Scheduled Appointments
  • Answered Phones
  • Greeted Clients

 

Education: Worcester Polytechnic Institute, Worcester, MA

Master of Science, Material Science and Engineering, WPI        May 2010

Graduate Research: Bacteria-Surface Interaction on the Nanoscale     

WPI Nanomaterials and Nanotechnology Lab and WPI Life Sciences and Bioengineering Center

  • Studied effects of nano and micro-sized surface geometry and size of surface features on bacteria adhesion/growth by growing Pseudomonas aeruginosa on anodized aluminum oxide templates (AAO) templates/membranes 
  • Preparing agar and media for bacteria growth
  • Plating bacteria
  • Biosafety Level 2 lab
  • Growing AAO templates/membranes
  • Sputter coating
  • Optical and Confocal Microscopy, SEM
  • ImajeJ

Bachelor of Science, Mechanical Engineering, Concentration: Biomechanics, WPI        May 2008

 

Technical Competencies:

  • Operating Systems:  Windows 95/98/ME/XP/Vista/7, Macintosh OS X
  • Software:  Microsoft Office, iWork, Adobe, Minitab, ProEngineer, SolidWorks, ImageJ, JobBoss
  • Other: SEM, confocal and light microscopy, profilometry, surface roughness concepts, Nitinol BFR testing, IQ/OQ/PQ, lean manufacturing, six sigma, GD&T, bacteria plating/growth, biological safety protocols, cleanroom protocols

 

Memberships/Activities:

  • Professional Memberships:  ACerS, ASM International, TMS
  • Other Memberships:  Alpha Gamma Delta Women’s Fraternity, Alpha Phi Omega Community Service Fraternity, Alpha Psi Omega National Honorary Theatre Society, Yankee Volleyball
  • Activities:  independent film production; classical ballet and pointe