Project Manager Medical Device
Resume:
James Kim 714-***-****
***** ***** **., ****** *****, CA 92844 __ ___ jkimjkim63@gmail.com__
PROFESSIONAL QUALIFICATIONS
I am a technical program/ project manager with exceptional experience in the medical device industry. My experience includes all phases of product development activities from concept stage, V&V, production transfer and commercialization. I have successfully developed numerous medical device products applying both FDA guidelines and ISO standards. I have the ability to direct and motivate cross-functional teams to meet both internal and external customer requirements to accomplish organizational goals and objectives.
EXPERIENCE ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION, IRVINE CA (3 MONTHS)
TITLE: R&D CONSULTANT (04/07 – Present)
• Provide expertise in design control area to support Design History File (DHF) remediation update plans.
• Manage biocompatibility requirements based on ISO 10993-1:2009.
• Reassess V&V, post market surveillance, complaint data to support Design Validation Requirements.
• Reassess Customer Requirements, Product Specifications and Product Requirements for DHF Update.
• Work closely with RA/QA to harmonize FDA, ISO, and internal SOP procedures.
• Update Risk Management plans per internal SOP and ISO 14971.
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EXPERIENCE INTERFACE CATHETER SOLUTIONS, LAGUNA NIGUEL, CA (2.5 YEARS)
TITLE: R&D PROGRAM MANAGER (11/07 – 4/10)
• Managed projects involving PTA, PTCA balloon catheters for both US and international companies.
• Prepare project timelines and milestones to meet organizational goals.
• Chair weekly meeting to provide project status to both internal and external customers.
• Provide sales/ marketing with engineering cost analysis to complete customer quotation process.
• Review V&V protocols and reports and EO’s based on Risk Management, FDA and CE requirements.
• Led cross-functional teams to ensure timely deliverables and expectations.
• Interface with RA/QA to ensure development activities meet both FDA guidelines and ISO standards.
EXPERIENCE INTERFACE CATHETER SOLUTIONS, LAGUNA NIGUEL, CA (2.5 YEARS)
TITLE: R&D PROGRAM MANAGER (11/07 – 4/10)
• Managed projects involving PTA, PTCA balloon catheters for both US and international companies.
• Prepare project timelines and milestones to meet organizational goals.
• Chair weekly meeting to provide project status to both internal and external customers.
• Provide sales/ marketing with engineering cost analysis to complete customer quotation process.
• Review V&V protocols and reports and EO’s based on Risk Management, FDA and CE requirements.
• Led cross-functional teams to ensure timely deliverables and expectations.
• Interface with RA/QA to ensure development activities meet both FDA guidelines and ISO standards.
EXPERIENCE SYBRON DENTAL (ORMCO DIVISON), GLENDORA, CA (2.5 YEARS) – NOW DANAHER
TITLE: R&D PROJECT MANAGER (3/05 – 10/07)
• Managed projects involving dental and orthodontic products.
• Provide effective leadership to project teams to increase productivity and streamline projects.
• Prepare project milestones and timelines to support organizational goals.
• Maintain DHF and CE Technical Files based on on-going risk management reviews.
• Mange bio-compatibility studies.
• Responsible for leading cross-functional teams to ensure timely product development, production release and commercialization of dental and orthodontic products.
• Interface with RA/QA to ensure product development activities to meet FDA guidelines and ISO standards.
EXPERIENCE MICRO THERAPEUTICS, INC., IRVINE, CA (5 YEARS) – (ev3) NOW COVIDIEN
TITLE: R&D ENGINEERING MANAGER (7/99 - 7/02)
• Managed R&D projects with emphasis on new product development efforts for neuro catheter market.
• Responsible for product development, production release and commercialization of medical device products.
• Set project milestones for engineers/ technicians to ensure timely deliverables and expectations.
• Created and managed budget and capital equipment requirements for R&D projects.
• Interfaced with physicians through human clinical, animal studies, and product discussions.
• Ensured product development activities include design control, FMECA, V&V under FDA guidelines and ISO standards.
• Attended clinical evaluations.
TITLE: SR. R&D PROJECT ENGINEER (12/97 - 9/99)
• Project leader for the design, development and production release of medical devices. Product areas include microcatheters, guidewires, and embolic agents.
• Investigated feasibility of new device concepts through physician interaction, clinical evaluations and animal trial.
• Created project plans to detail project tasks, timelines and resources.
• Generated product and design specifications meet marketing requirements.
• Performed DOE experiments to optimize design and implementations.
• Generated protocols for design verification to meet FDA guidelines and ISO standards.
• Supervised group of product development technicians and engineers.
TITLE: MANUFACTURING ENGINEER (7/96 - 11/97)
• Validated and transferred new product and processes from pilot production into full manufacturing facility.
• Generated experiments to optimize processes to maximize product performance and minimize process validations.
• Developed test methods and performed statistical analysis of data to determine process capability.
• Developed new processes, tooling and equipment to lower standard costs.
• Evaluated product returns and implemented corrective action procedures to eliminate performance issues.
• Created documentation that includes drawings, W/O’s, BOM’s and manufacturing procedures.
EXPERIENCE BAXTER HEALTHCARE CORPERATION, IRVINE, CA (10 YEARS) – NOW EDWARDS LIFE SCIENCE
TITLE: R&D ENGINEER (6/87 - 6/96)
DIVISION: LESS INVASIVE SYSTEMS (LIS)
• Responsible for development of various Fogarty catheters, clips, and clamps.
• Developed and transferred Fogarty Thru-Lumen product line from Irvine facility to Puerto Rico plant.
• Supported development efforts of various coronary products: PTCA catheters, guidewires and inflation devices.
• Provided support to production, manufacturing and QA in assisting changes and validations.
• Reviewed product verification data for device release criteria.
TITLE: R&D TECHNICIAN (7/87 - 5/93)
DIVISION: LIS
• Provided technical support to IV Pump monitor for C&C machining and inspection.
• Provided technical support to coronary and Fogarty product development teams.
• Fabricated prototypes and generated test methods and performed feasibility testing.
• Designed, built and validated various fixtures to support testing of existing and new products.
• Assisted in product transfers to production and provided training to the operators.
TITLE: SUPERVISOR (4/86 - 6/87)
DIVISION: LIS
• Supervised a group of assemblers and technicians for coronary and vascular production lines.
• Traced work orders and standard hours to determine production efficiency.
• Prepared and reported production control charts to operations meetings.
• Supported engineering group with verification builds and experiments.
PATENTS AND AWARDS
• Large Proximal Lumen Micro Catheter
• Reinforced Micro Catheter
• Baxter Healthcare; Marathon Guide Catheter, Technical Award; 1989
• Micro Therapeutics; Employee of the Year; 1998
COMPUTER SKILLS
Knowledgeable with following software programs: MS Project, Word, Excel, Power Point, and AutoCad
EDUCATION
1996 BS, Business Administration, University of Phoenix, Fountain Valley, CA
1988 AS, Electronic Technology, Rancho Santiago College, Santa Ana, CA
1986 Machinist Certificate, Rancho Santiago College, Santa Ana, CA
Specialized Training in Project Management Professional, Six Sigma, Failure Mode Effect Analysis, FDA Design Control and ISO Standards.
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