SUMMARY:

• Mechanical Engineer with 8+ years of experience and a wide range of technical skills in the automotive, machine tool industry and medical devices fields. Primarily focused in the medical devices field. Enjoys being part of a team as well as managing, supporting and others; thrives in challenging working environments. Supports corporate objectives by providing information and recommendations to management. Communicates to the organization regarding changes to product, packaging and collateral through formal and informal channels.

TECHNICAL SKILLS:

SKILLS: Skills and GD&T, Design for Manufacturing, Microsoft Office Suite (Word, Excel, PowerPoint, Visio, Project, Outlook) Abilities SolidWorks/Cosmos (3D CAD Design, Finite Element & Stress Analysis), Tolerance Evaluation, Matlab/Simulink, Labview, Ricardo Wave, FARO CAM2 Measure, SAP, Mastercam Technical Welding of Steel and Aluminum using TIG, MIG and ARC welding process, Laser Welding of various metals, SkillsMilling and Turning operations on various materials, Fabrication of tooling or complex components

PROFESSIONAL EXPERIENCE:

Senior Mechanical Engineer

Confidential, Valencia, CA

Responsibilities:

• Lead Mechanical Engineer on an Implantable Sensor used for the control of prostheses that have motorized, articulated joints controlled by electromyographic (“EMG”) sensors on the residual portion of the human limb.
• Responsible for conceptualizing and creating three main configurations of the Prosthetic Frames (prosthesis) based off of 25th, 50th and 95th percentile US and European Anthropometric Data. These configurations eliminated the need for specific custom made prosthesis; reducing manufacturing lead times and costs.
• Design for Manufacturability (DFM) on the three individually sized Surface RF Coils used to power and communicate with the implanted devices.
• Designed the housings and overall layout of the individual components throughout the Prosthetic Frames such as the Surface RF Coils, telemetry controllers, lithium - ion battery packs and prosthetic controller to allow for proper transmission of the EMG signals from the Implantable sensors to the embedded Surface RF Coil.
• Design of plastic injection molded parts such as eyelet attachments for the Sensor, sub-system component housings and surgical tools.
• Perform FEA on plastic and metal components utilizing Solidworks DFM analysis tools.
• Responsible for the Mechanical Designs, Manufacturing Documents, and implementation of methods for production as necessary to support new product introduction (NPI) or product improvements.
• Responsible for the CNC programming and laser welding parameter characterization for hermetically sealing the Implantable Sensor Cases.
• Created new Laser Welding Procedures with simplified assembly processes for Manufacturing Personnel.
• Designed medical devices utilizing materials for long term implant applications in compliance with Class II and Class III regulations.
• Developed manufacturing assembly fixtures and communication fixtures.
• Managed projects by ensuring design, deliverables, and documentation were performed to design and performance requirements and specifications, on schedule, and in budget.
• Collaborated with Manufacturing, Medical Affairs, Document Control and other departments to document user and product requirements.
• Managed cross-functional teams and selected third-party vendors and service providers such as design firms, and test laboratories for shipping/transport testing per ISTA - 2A and basic safety and essential performance testing per IEC 60601-1 standards.
• Interfaced with vendors and established requirements in order to achieve fast delivery of materials and services reducing lead times and estimated project finish dates.
• Responsible for completion of all phases of the product development cycle, from concept through design transfer. Executed Design Verification Testing (DVT) and Validation planning including IQ/OQ/PQ, active cross-functional failure analysis investigations and resolution activities. Participated in change control, material review boards, quality system reviews as operations and mechanical engineering representative.
• Supervised and mentored Manufacturing Personnel and Technicians in proper assembly techniques and steps from the introductory phases of new projects through final DVT assembly builds.
• Responsible for documenting product requirements and design, and assured the Design History File (DHF) was complete.
• Trained on SOP’s per FDA 21 CFR 820 and ISO 13485. Accountable for CAPA’s, field corrective actions, nonconforming material processes and quality system related responsibilities.

Manufacturing Engineer

Confidential, Oxnard, CA

Responsibilities:

• Lead manufacturing Engineer solely responsible for the sustenance and high production output of two major assembly lines.
• Supervised and trained Assemblers in the development of assembly processes.
• Developed and Implemented new tooling and fixtures which improved assembly processes and reduced cycle times.
• Active as Lead Manufacturing Engineer in collaboration with Design Engineering Teams to improve manufacturability and address potential design issues for new product introduction.
• Practice of Lean methods to reduce waste and improve efficiency through the use of Value-Stream Models and improved floor lay-outs.
• Conducted root cause analysis using tools such as Pareto Charts, Fishbone Diagrams and 5 Whys.
• Maintained and created Bills of Materials, Work Instructions, Shop Drawings, Engineering Change Orders, Routers and Tooling for multiple projects simultaneously.
• Troubleshooting and problem solving of complex mechanical, pneumatic and hydraulic systems through extensive research and testing.

Mechanical Engineer

Confidential, Hawthorne, CA

Responsibilities:

• Research and Development of various cold air induction and filtration systems for internal combustion engines through implementation of fluid dynamic theory.
• Flow bench tests, dirt retention tests, and vehicle dynamometer tests with the objective to create efficient filtration systems and improve power output.
• 3D Design of vehicle induction system components and assemblies using SolidWorks and FARO CAM2.
• Communicating with vendors and factory personnel to achieve higher production output.
• Responsible for creating Bills of Materials and for all facets of Inspection duties (Source, First Article, Receiving, In-Process and Final Inspection).
• Rapid Prototyping of Pre-Production sample pieces.
• Extensive modeling and creating prints for roto-molded, injection molded, machined components and sheet metal parts.