Sr. Product Development Engineer

Posted on: 2006-06-20

TERESA GUICHARD 12652 Ellison Wilson Rd., North Palm Beach, Florida, 33408 H (561) 627-1814; C (561) 676-4036; e-mail: [email protected] SUMMARY OF QUALIFICATIONS A Senior Product Development Engineer with knowledge of FDA Design Control. Over 20 years experience in Medical Device Product design and Project Management for a Medical Manufacturing, Jet Engine Manufacturing, and Appliances Manufacturing Corporations. Most proficient in Solid Modeling on Pro/Engineer (over 6,000), CadKey (over 8 years) and Autodesk Inventor (5 years, current). Proficient in computer skills in various managing Software. Strong ability to define and detail mechanical designs from concept to finished product, develop models and assemblies to applicable regulatory standards, including validation and verification procedures, by using the most expeditious and effective methods. Good knowledge of tooling, injection molding plastics and other processes. Excellent ability to prioritize and work alone or in a multi-functional team environment. PROFESSIONAL EXPERIENCE 3i IMPLANT INNOVATIONS, INC. Palm Beach Gardens, Florida September 17th 2001 – June 16th 2006 Manufacturer of Dental Implants and Dental restorative Components Senior Product Development Engineer • Performs product development activities on assigned projects in accordance with projects design guidelines. Prepares detailed product design layouts and supporting tolerance analyses. Develops detail and assembly documentation to support production release. Generates and maintains design history data for product development activities. Confers with other personnel to clarify or resolve problems for design development. Helps coordinating manufacturing of pilot and initial production for assigned projects. Records all stages of design per required procedures utilizing computer skills. Monitors projects in critical junctions. Coordinates interdepartmental technical information transfer regarding product development activities. Creates verifications/validation protocols and reports. Participated in a re-write of Design Control Operating Procedure. . PARAMETRIC SOLUTIONS, INC. , Jupiter, Florida 2000 –2001 Consulting Engineering Firm Mechanical Designer • Documented all stages of design utilizing computer skills from concept to final stage per customers specification. HUNTER FAN COMPANY, Memphis, TN 1999 – 2000 Manufacturer of ceiling fans, air purifiers & humidifiers and other home comfort product and accessories Development Engineer • Documented all stages of design from information provided by Industrial Designers or Marketing, from concept to released product. Provided functional analysis to the mechanical design development & implementation on design documentation. Monitored projects in critical junctions. Successfully designed, processed and released projects for ceiling and table fan assemblies. GE - Marquette, Jupiter, Florida 1990 – 1999 Manufacturer of supplies for monitoring & diagnostic equipment for hospital care. (1996 – 1999) - Mechanical Design Engineer • Provided functional analysis to the mechanical design development & implementation on design documentation. Documented all stages of design & required specifications utilizing computer skills. Meets the prescribed schedules. • Successfully designed, processed and released several projects for cable assemblies used on patient monitoring & diagnostic equipment. Participated in varied engineering jobs, new and sustaining projects. • Developed and designed a streamline approach for attaching a lead wire to the patient electrode. (Patent Pending) • Ensured adherence to regulatory requirement standards, FDA, ISO 9000, GMP, GMED in design and mfg. processes. • Product Engine Team Leader for project scheduling improvement. • Participated in a rewrite for division Design Manual. Was selected to revise the verification and validation procedures. Prepared presentation and trained personnel regarding the procedures. (1990 – 1996) - Design Detailer ? Managed Document Room when Jupiter Division opened facility in Florida in 1990. ? Participates in varied engineering jobs, new and sustaining projects, requiring substantial originality. ? Made choice in purchase Engineering Department first CAD Software (CADKEY). Provided assistance on CAD problems to other associates. ? Wrote Divisions first Drafting Manual for Supplies Engineering Department. ? Continually acquired additional responsibilities and was promoted to Design Engineer in 1996. UNITED TECHNOLOGIES - Pratt & Whitney, West Palm Beach. Florida 1989 – 1990 Jet Engines Manufacturer Drafter • Provided quality drawings striving for an error free product. Required knowledge of geometrical feature control requirements and ANSI standard dimensional requirements. Reason for leaving: Lay-off PURITAN BENNETT – Lenexa, Kansas 1980 – 1989 Manufacturer of respiratory equipment for hospital care Designer • Draw and release mechanical and electronic engineering documents of relatively complex nature. Made calculations and study of interrelated parts. Participates in varied engineering jobs, new and sustaining projects. Reason for leaving: Moving to Florida RIVAL – Raytown, Missouri 1979 – 1980 Manufacturer of small house appliances Drafter • Worked on small engineering projects, making original contributions to design, from hand drawn sketches, oral discussions or partial information supplied by project engineers. Reason for leaving: Re-call from Puritan Bennett PURITAN BENNETT – Lenexa, Kansas February 1979 – August 1979 Manufacturer of respiratory equipment for hospital care Drafter • Worked on diversified engineering assignments, gathered basic data using defined procedures. Reason for leaving: Lay-off EDUCATION • Lyceum of General Education in Memory of Boleslaw Chrobry, Sopot, Poland • Technical School of Engineering Design, Gdansk, Poland • Platt College, Overland Park, Kansas, 1979, ADDITIONAL TRAINING • AutoCAD, 1999 • AutoCAD Inventor, 2001 • InterGraph, Basic,1988 • InterGraph, Advanced, 1989 • ComputerVision, 1989 • UniGraphics, 1990 • Inventor, 2001 • CadKey, 1992 • Pro-E, Basic, 1994 • Pro-E, Adv. Model, 1997 • Pro-E, Production, 1997 • Pro-E, IntraLink, 1997 • Pro-E Adv. Prosurface, 1997 • CorelDraw, Adv, Graphics • MS Word Processing • MS Excel • MS Project • Effective Project Management for Validation, 1997 • The New GMP Workshop • Submitting your 510(k) for Expedited Approval • Critical Regulatory Documentation Requirements • Effective Project Management for Validation, 1997 • The New GMP Workshop • Solving the Plastic Product Design & Development, The University of WI, Milwaukee, 1998, 2.8 CEU • Computer Aided Part & Mold Design/Mold Sim. University of Mass., Lowell. 1998, 3.75 CEU Earned LANGUAGES ORGANIZATIONS • French – speak fluently, write intermediate ü International Society of Plastic Engineers • Polish – speak and write fluently • Russian – studied 7 years