Medical Device Manufacturing / Project Engineer Resume Monument, CO - Hire IT People

SUMMARY:

Skilled in cell design with automation. Utilize clean - TEMPprincipal process development, improvement, and validation in highly regulated FDA screw mass-volume production products.
Expertise in aerospace and sonar components manufacturing, for assembly operations ranging from medical device sensors, aerospace hydraulic system, and naval sonar subsystem.
Strong communicator, building and leading cross-functional, collaborative team dynamics, team building in establishing production workflow and improving throughput. Fluent in Vietnamese.
Project Management for process design, cell design, new capital appropriation, automation, FDA compliance, new product design transfer, existing product transfer from vendor or sister work site.
Clean principle Manufacturing (JIT, Demand Flow Technology)
NCR and CAPA Investigation
PFMEA, process risk management, tech file remediation
Robots & Vision system for automation
Design for Manufacturing (DFM), Concurrent Engineering
Forming,Machining, and Grinding
Gage R&R, Test method validation, IQ, CSV, PFMEA, OQ, and PQ per ISO 13485, FDA
3D printing fixtures for work cell design,
Gauge, Tooling, CNC, PLC
Team for both operators and engineers which include step by step JBS (Jobs Break Down) sheets, video and knowledge comprehension test.
Process Design & Data Analysis (correlation, ANOMA, ANOVA)
Design of Experiment (DOE) include screen, process and product optimization DOE
Iso 9000 TQM (Total Quality management) certified and implementation (equivalent to Six Sigma’s DMAIC process)

TECHNICAL SKILLS:

Drafting and design: AutoCAD, ProE

CNC: Mastercam, Data collection, extraction

Analysis and DOE design: Stat graphic, Minitab, Excel, Access, SQL

Project management: MS project, Playbook, Quality system ETQ, ERP system JDE, MAPICS, Process flow Visio

PROFESSIONAL EXPERIENCE:

Confidential, Monument, CO

Medical Device Manufacturing / Project Engineer

Responsibilities:

Utilized Concurrent engineering techniques, including screen and response surface DOE, developing medical screws for challenging cranial and mandible bones applications resulting in more than $20M in annual sale.
Utilized cloud based project management tool like Microsoft project, Playbook to manage product transfer from design stage to manufacturing stage for new product launch which include design review, gaging, routing and process development. Project management for design transfer from vendor work site to production work site for cost saving due to in house process automation.
Directed new product launch projects and concurrent manufacturing teams, introducing new trauma treatments applications ranging from minimally invasive surgery via lock screws system to new nail screws to minimize insertion torque for fast surgery and reducing bone loss leading to sales of $100M annually.
Led multiple international teams spanning continents from USA, China, Brazil, and Switzerland, using cloud technology, harmonizing product and process design, minimizing manufacturing cost while elevating profits and satisfying global regulatory requirements TUV, FDA and ANVISA.
Designed and optimized work cells using clean principles, eliminating non-value-added activities while maximizing product throughput, using usage of 3D printing fixturing and Poka Yoke devices.
Trained junior manufacturing engineers in process development and validations, creating knowledgeable and adept workforce.
Oversaw day-to-day production support, NC root causes analysis, CAPA analysis, championing and solving numerous NC and CAPA issues, allowing company exit FDA 483 warning letter.
Interacted daily with vendors, developing tooling, machine selections, process risk analysis, process development, and process capability, allowing vendor pass process validation requirements as acceptable cost.
Develop and validate start to end cleaning systems as well as non-sterile packaging for class III medical screws to ensure passing toxicology and residue analysis requirements per FDA guidances.
Developed numerous test protocols for gage study, process study, process risk analysis (PFMEA) and pre OQ process validation, producing stable and capable processes.
Managed process design, optimization and process validations within FDA guidance, including IQ, CSV, OQ, PQ, PFMEA, GAGE R&R and process monitoring, fulfilling regulatory requirements and maintaining compliance.

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Medical Device Manufacturing / Project Engineer Resume

Monument, CO

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