Walter Galvez Email & Phone Number

Silver Spring, Md, Us

Herndon, Virginia, Us

Herndon, Virginia, Us

Herndon, Virginia, Us

Piscataway, Nj, Us

Union, Nj, Us

• Teach Industrial Design (ID) Students the fundamentals of Manufacturing Processes and Materials• Prepare syllabus, lectures, exams, and projects to evaluate student performance each semester• Collaborate with other industry professionals/professors for continual improvement of undergraduate ID curriculum• Mentor and guide students throughout the course to understand design for manufacturing in industries of interest

Franklin Lakes, New Jersey, Us

• Serve as R&D lead of cross-functional team and internal subject matter expert on projects, including integration of Arterial Blood Gas syringe product line with safety needles and development of next generation Blood Collection tube• Conduct Project Management activities in accordance with Design for Six Sigma, maintaining plans in Microsoft Project• Coordinate with Clinical and Research Lab staff and teams in the UK and Singapore to plan and implement all project activities• Create and maintaine documentation, such as Project Plans, Test Protocols, Test Procedures, and Reports• Contribute to development of NPD SOPs, Work Instructions, and other controlled documentation• Develop in vivo and in vitro test methods to evaluate product capabilities and concept feasibility• Analyze data using statistical tools (Minitab), regression analyses, and develop transfer functions

Kalamazoo, Mi, Us

• Served as R&D lead of cross-functional team that included Regulatory, Quality, Operations, Packaging, and Sterility• Designed Custom Implants per surgeon specifications, as well as X-Rays, MRI, and CAT scans• Conducted quality assurance review of projects and ensured customer (surgeons and patients) needs were met• Analyzed Risk using tools such FMEA and FMECA• Compiled and prepare documentation for FDA Compassionate Use submission• Successfully implemented dozens of patient specific implants for hips, knees, shoulders, and elbows

Franklin Lakes, New Jersey, Us

• Served as R&D lead of cross-functional team and internal subject matter expert for various resin change projects • Managed various multi-phase gated Projects through Design Verification and Validation with tight deadlines• Developed project plans that included project tasks, deliverables, and resource requirements in Microsoft Project• Maintained regular communication with team members in the US, Mexico, and Brazil and track their assigned project tasks• Generated and maintained Design History File documentation, including writing 510k submissions, Design Verification (DV) plans, DV Reports, DV test protocols, etc., per ISO 13485 QMS and FDA requirements• Conducted feasibility/engineering assessments and statistical analysis of conceptual prototype devices• Successfully advanced several multi-year projects worth $2MM in cost savings to release phase

Shelton, Ct, Us

• Designed and Developed concepts and prototypes for medical devices using SolidWorks and ProE• Performed Tolerance Stackup Analysis on designs• Created and Maintain DHF documentation per ISO 13485 QMS and FDA requirements• Developed design testing methods and procedures for electrical and mechanical testing based on industry standards• Built test fixtures as necessary for inspection and testing by utilizing available mills and lathes, as well as external vendors

Morristown, New Jersey, Us

As an Engineer at HS-Design, I'm involved in various ongoing projects at all times. Responsibilities have included everything from refining designs to become functional and practical to managing projects from design kick-off/transfer all the way to manufacturing. -Collaborate with diverse cross-functional product development teams-Apply knowledge of human body/tissue behaviors and human factors (per HE-75) to device design-Design and Develop parts and assemblies using SolidWorks-Develop plastic injection molded parts-Develop metal cast and machined parts-Create complete documentation for a product, including technical drawings, specifications, and instructions-Design and implement comprehensive verification and validation testing protocols-Create Assembly Instructions for manufactured devices-Use Solidworks Simulation Pro to perform FEAs, including static analysis of parts and complex assemblies, nonlinear studies of polymeric materials, thermal analysis(often combined with static studies), Buckling analysis, Pressure Vessel analysis, Drop Test analysis, Fatigue testing, Bolt Torque Specification, and CFD analysis.-Optimize device designs by doing various design studies in Solidworks-Verify models using prototyping services such as SLA,SLS, Urethane Casting, etc.-Use in-house FDM 3D printer to verify modelsIn addition to designing, the engineering team maintains and implements the QMS. I've been trained as an Internal Auditor by BSI Group and am also an Alternat Management Representative. My QMS responsibilites have included:-Establishing and retaining certification (ISO 13485:2003 and 9001:2008)-Conducting Internal Audits-Maintaining and Improving the QMS by conducting document reviews-Handling CAPAs-Create and follow a Design process in compliance with FDA for medical devices

Edison, New Jersey, Us

-Shadowed Clinical Veterinarian and Research Animal Technicians -Observed and assisted in over 40 practice Robotic Telescopic surgeries ran by Intuitive Surgical Inc.-Became familiarized with Da Vinci robot, procedures, devices, and limitations -Learned Research Animal Policies and Procedures through AALAS online courses

-Manufactured instruments and implants used in surgery such as Carpal Tunnel tissue separator, cable tensioner parts, Aluminum handles for surgical use, and lag screws-Operated and programmed (G code) CNC mills and lathes in an ISO 9001 Environment-Designed and edited blueprints and drawings for parts

Bachelor Of Engineering, Biomedical Engineering

Education record