Post Job Free

Resume

Sign in

Medical Device Engineer

Location:
United States
Salary:
80000
Posted:
June 02, 2015

Contact this candidate

Resume:

Frank Hu

***** ******* ******.

Moreno Valley, CA 92555

TEL: 909-***-**** (C); E-mail: acp0no@r.postjobfree.com; Skype: foxlinkla125

EDUCATION:

. Tennessee Technological University - Cookeville, Tennessee. M.S., Mechanical Engineering focus on automatic control & manufacturing.

. Tam-Kang University- Taipei, Taiwan. BS -Mechanical Engineering focus on manufacturing.

OBJECTIVE:

To participate in 3C products (mainly consumer electronic device), medical device (class II & Class III), aerospace components manufacturing

professional organization as a NPIE (New Product Introduction Engineer), project engineer, program manager, sr. mechanical engineer, product

engineer, tooling engineer, quality engineer, or manufacturing engineer & grow together with new organization.

CORE COMPETENCE & SKILL SUMMARY:

15+ years of OEM/JDM/EMS/CM 3C & medical device (class II & III) new product development/validation, manufacturing, mechanical engineering support & project

management experience, primarily in consumer electronic devices such as cellular phones and accessories, BT headsets, speaker, and docks, gaming controller, and console,

wearable devise, 320G~3TB EDA, NAS, smart watch, 3D controller. Medical devise include lancets (class II), fluid transfer devices & catheters (class III) for blood test &

surgery.

Proficient with plastic component design/material selection/tooling/injection molding, secondary process, surface finish, sheet metal design, stamping, casting, and

forming. Ability to hand on resolve tooling and process issues to meet new product requirement.

Effectively lead & manage consumer electronic & medical programs to ensure products comply with design, cost/budget, schedule, manufacturing, regulatory, and agency

requirements. Set-up quality/test plan and ensure product complied to customer’s spec, FCC/FDA, and safety/environment regulations.

Have over 15 years of consumer electronic & medical devices’ NC, CAPA (Corrective Action & Preventive Action), MRB (Material Review Board) and SPC (Statistic Process

Control) QC area's experience. Have Quality Manager’s experience & skill with strong quality control area’s (IQC,OQC, TQC, SIP…) knowledge.

Ability to work within a fast paced, multi-national environment with personnel located in USA, Taiwan and China; multi-tasked, detailed and deadline oriented. Strong DFM and

NPI skills. Familiar with Six Sigma process improvement and Lean Principles for cost reduction.

Hand on mechanical components design & validation test, EMI, vibration and shock, stress and strain, heat transfer/sink, plating, coating

and heat treating, material strengths, drawing layouts, geometric dimensioning and tolerances (GD & T/ASME Y14.5) & quality assurance and

control principles/practices. Knowledge of medical device regulation MQMS process - ISO 13485 (process certification), ISO14971 (risk

management), 510(k)-PMA (Pre- Market Approval), & 21CFR part 820 quality system regulation, EU Medical Device requirements – Council Directive

93/42/EEC & Medical Electrical Equipment – EN 60601.

Works closely with a cross functional team of Designers, Product Managers, Purchasing, and Sales on new concepts and approaches to the design

or development of new or improved products or components.

Computer skill: Pro-E Wire Fire3.0 & 5.0; CRE-O 2.0, Solid-work 2006, Solid-work 2012, Auto CAD, Word, WordPerfect, Excel, Power Point,

Microsoft Project Management.

Languages: Fluent in English, Chinese (Mandarin), and Taiwanese. Basic level in Japanese.

EXPERIENCE:

Esterline, NMC Technology Inc. (Aerospace component, specialty fasteners and custom molding manufacturer, (http://www.esterline.com))

Tooling & Project Engineer (Current job) Jun. 2014 ~ Feb., 2015

2755 Thompson Creek Road, Pomona, CA 91767; Tel: 909-***-**** Ext. 515

• Responsible for aerospace (mainly Boeing & Airbus), & medical components (applicators) specialty components, fasteners and custom molding, tooling development,

qualification, manufacturing, & project management from concept through mass production & sustaining. Use Solidwork 2012 for 2D & 3D components &

tooling design.

Foxlink International Inc. (OEM,EMS, & JDM manufacturer, (http://www.foxlink.com/) )- Sr. Mechanical/Project Engineer Nov. 2005 ~ Nov., 2013

925 W. Lambert Rd. Suite C, Brea, CA 92821. Tel: 714-***-****

• Responsible for OEM/JDM/EMS 3C products (mainly consumer electronic device) & medical device (class II & III) new product design (R&D), development,

manufacturing, quality control & project management from concept through mass production & sustaining.

. Provide new product/project’s RFQ (quotation/cost) & ROI (Return On Investment), quotation, cost analysis to get business or project awarded by

customers.

. After project awarded for each of 3C product & medical device new project take lead to form cross function team, take leader ship & prepare new

project plan/proposal, development schedule, budget and conduct project/risk & time management/leadership via weekly conference call with

internal cross function team (include marketing/sales, R&D (ME/EE/Software/Hardware), manufacturing (PE, QC, plastic injection, sheet metal

stamping, die casting, CNC machining, 2nd operation (plating, painting, surface polish.) purchasing dept supplier & customer for all new

projects. Monitor & control new projects to ensure new

project/product completed/delivered on schedule & within budget.

. Consumer electronic & medical devices’ production lines & customer complaint support & sustenance - NC, CAPA (Corrective Action & Preventive Action), MRB (Material

Review Board) and SPC (Statistic Process Control) QC area's experience. Have Quality Manager’s experience & skill with strong quality control area’s (IQC,OQC, TQC,

SIP…) knowledge.

. Hand on new 3C product & medical device project’s design & design control: interactive with internal R & D and customer’s engineering team

use Pro-E wildfire 5.0 & Solid work 2006 to finalize sheet metal/plastic component/assembly detailed design & generate ID, BOM, 2D drawing &

3D model for manufacturing. Carry out EMI, noise, vibration, DFM, DFC, & DFA issue analysis, dimension tolerance stack-up (GD&T/ASME

Y14.5), FEA & ANSY mold flow analysis, FMEA or PFMEA (Process Failure Mode Effect Analysis), execute design change & control, release

ECN/ECO to the team.

. New 3C or medical product’s manufacturing (plastic parts injection molding, rubber parts’ compress molding, sheet metal parts stamping, die

casting, extrusion, & assembly) & tooling development (soft-tool & hard tool (include double shot, IMD & IMF), stage die & progressive die),

equipment, & fixture design/development/trial run (T0~Tf), 2nd operation process & planning (painting, plating, polishing, passivation, coating,

sand blasting, CNC machining), components & finish goods cosmetic inspection spec & standard inspection process (SIP) preparation & FA, FAI,

Cpk approval.

. Hands on 3C product & medical device new project CNC, SLA, SLS, silicone quick mold, 3D printing prototyping, mock-up sample preparation

& validation test.

. Conduct 3C & medical device new project ES, EVT, DVT, PVT build & validation test (ME/EE/functionality/durability/Gage R&R), on line

support & technical problem solving.

. 3C product & medical device new product/project’s manufacturing process (LEAN & 6 sigma) & production line planning (layout,

equipment/fixture/manpower) & set-up. Manufacturing process optimization (OEE/TEEP improvement). Risk management & mitigation: conduct

PFMEA, FMEA & control RPN over 80%.

. 3C product & medical device production line or customer complaint CAPA, NC issue resolve, MRB, SPC, 6 Sigma (Gage R&R/DMAIC) quality

control system (IQC, OQC, TQC, SIP, Gantt chart,…) set-up, & quality control/test plan/protocol preparation & execution to ensure new product

meet customer’s quality spec & compliance to external regulations.

. Responsible for 3C & medical device new product compliance with Regulatory Agencies. Knowledge on UL/CE/FCC certification & FDA

medical device MQMS process ISO 13485 (medical device process certification), ISO 14971 (risk management), Title 21CFR part 11~814 & 820

(Quality System Regulation). 510(k) PMA (Premarket Approval) clearance.

. Over 35 projects completed successfully each project bring in company $5M~$40M revenue annually. Project including: MS (controller,

mouse, & headset), Nintendo (controller), Motorola (Smart phone, blue tooth headset), Symbol (RF bar code scanner) & Seagate (Raptor, Rockit,

& Satellite (WiFi), Phoenix 320G~3TB EDA, Cirrus NDR (Network Data Recorder with Wi-Fi router), Smart Adaptor), Abbott (medical lancet &

catheter), Basis MiG smart watch (with Wi-Fi design), Leap-motion dual RF 3D motion controller.

.

Foxconn, NWE Technology (World’s largest OEM,EMS, & JDM manufacturer)- Mechanical/Product Engineer Jun. 2000 ~ Oct. 2005

1688 Richard Ave., Santa Clara, CA 95050 (http://www.foxconn.com/index_En.html; http://www.nwetechnology.com/) Tel: 408-***-****.

• Cisco network system new product/project mechanical components’ design, development, testing & manufacturing, CAPA, 6 Sigma quality

control system & project management/leadership including the preparation of project schedule, product spec, BOM, 2D & 3D drawings, ID,

CMF, DFM/DFA/DFC issue analysis, SOP, SIP, prototyping, sheet metal (server/router chassis, tray, bracket) soft tooling and hard tooling,

plastic components (IP Phone, bezel, light pipe) molding/injection/FEA/ANSYS mold flow analysis, FAI sample & Cpk (process) approval.

Use Pro-E wildfire 3.0 &5.0, Solidwork for JDM new product/project design. Pre-pilot/pilot run until mass production transfer to sustaining.

Production line engineering support.

• Cisco System server, router, network rackmount, sheet metal & plastic enclosure, plastic mechanical component/bezel/ faceplate/light

pipe/trays/bracket & backplane design, development, manufacturing & integration for the Cisco System new product project such as IP

Phone, 1700, 6160, 6260, Surfer, Flamingo, Lord of the Ring. Cisco 1 RU to 6 RU network chassis/enclosure, level III to level VI integration.

About 28 projects completed successfully. Each project bring in company $5M~$60M revenue annually.

InterMag Inc. (Data Storage Media manufacturer, 4910 Raley Blvd., Sacramento, CA 95838) 1995 ~ 2000

. Engineering & Quality Manager (3 years), Tel: 916-***-****

•Optical disc mastering, replication, printing, & packaging.

•CD, CDR, & DVD manufacturing engineering, ZIP jewel case plastic component injection molding, 2GB Removable hard disk

manufacturing engineering.

•Product Engineering & Quality system (BOM, FPS, ECN, SOP,SIP, IQC, OQC, TQC, CAPA) set-up & maintain, department supervision,

training, & leadership (2 shifts, 30+ engineers & technicians).

•Production equipment modification & improvement. Lead & conducted ISO-9001 certification successfully for InterMag in 2000

.

. Project & Logistic Manager (2years)

•Reverse roller magnetic coating system/coating head upgrade. Extruding die coating system R & D and implementation.

•Media calendaring, compounding, slitting & punching operation management. SOP (spin on & peel off) technology development.

• Warehouse & kitting area material handling operation, inventory, stocking, loading/un-loading, and shipping/receiving.

• Daily warehouse & logistic dept. supervision (10+ operators & staffs) & prepare MPS (Master Production Schedule), inventory count &

execute inventory control.



Contact this candidate