- Electronic circuits design, including creating schematics, BOM, PCB
layout and board testing specifications.
- Created the mechanical design requirements and the initial
mechanical design sketches.
- Created and implemented design verification and validation plans and
protocols.
- Insured the design compliance with ISO 21647 and FDA, GMP
requirements.
- Provided sustaining engineering support to current production
products.
- Managed production in the US facility and supporting the multiple
overseas facilities (i.e. India, China).
- Planned and executed daily manufacturing activities to ensure
products quality and on time delivery.
- Managed manufacturing engineering activities to ensure proper
product transfer from engineering to manufacturing, including early participation
in the product design, lean manufacturing processes design, quick response
manufacturing implementation, test fixtures design, automation and developing
product manufacturing and quality documents.
- Supported the implementation of FDA GMP and ISO processes for new product
development, manufacturing, and regulatory requirements. Also supported
FDA, ISO and UL Audits.
- Managed the daily operation planning to ensure timely product delivery.
- Managed a 20% smaller manufacturing team and a 60% smaller
manufacturing engineering team to sustain steady sales (30M annual) with reduced
budget through the economic down turn.
- Implemented the Intern/CO-OP program in the manufacturing department,
focusing on bringing in and developing new talent.
- Directed pilot production activities for new products and managed
design transfer into overseas facilities.
- Participated in the release of the company key new products: Multi-parameter
vital signs monitoring devices, and the new N2O-CO2 OEM module.
- Participated in the integration with Opto Circuits Ltd and Unetixs
Vascular (PAD).
- Participated in the design of the next generation gas module.
- Modified and implemented high level quality system policies and
procedures.
- Provided continuous training to all department personal, to insure
complete job knowledge and to guide employees in building a self learning
mindset.
- Participated in the products early design stage to ensure a better
design for manufacturability, DFM, DFA, quality and profitability.
- Implemented Lean manufacturing processes and quick response
manufacturing (QRM).
- Designed and implemented automated test fixtures, including
mechanical, hardware and software design.
- Implemented product design and manufacturing processes changes to
maximize production yield minimize cost, and enhance the quality of
current production products.
- Estimated manufacturing costs of parts, assemblies, materials,
overhead and tooling.
Technology Consultant (part time)
- Installed, calibrated, maintained, and trained hospital crew on the
use of Image Guided Surgery equipments IGS (Surgical Navigation Systems).
- Provided on site equipments troubleshooting and repair services.
Owner (Part time work)
- Family owned and operated business that provided broad medical
equipment services including: repair, test, calibration and preventive
maintenance for a broad range of medical devices including Vital signs
monitors, Electrosurgical units, Surgical tools, Sterilizers, EEG/ECG/EMG monitors,
Operating room tables, Syringe drives, Infusion pumps, Oximeters, X-Ray
equipment, Ultrasonic imaging devices, Anesthesia monitors and Ventilators.
- Designed and built custom surgical tools based on ideas proposed by
surgeons and nurses.
- Manufactured broad range of medical devices accessories including ESU
foot-controls, Bipolar and Monopolar forceps, cables and ESU pencils. Also
manufactured a verity of ECG and Oximeters cables.
- Participated in the outsourcing of key production lines into
overseas facilities (India and Singapore).
- Participated in the planning and implementation of the Criticare /
Unetixs Vascular Inc Merger.
- Participated in the planning and implementation of the relocation of
Criticare Systems Inc to its new facility.
- Restructured the Manufacturing department after the acquisition of
Criticare Systems by Opto Circuits Ltd.
- Developed automated test fixtures for electronic circuit tests,
pneumatic sub assemblies test, final assembly tests, and product quality
controls tests to improve yield and reduce production cost.
- Developed automated Calibration/QC test fixtures for medical
anesthesia gases monitoring systems which resulted in doubling the
production capacity.
- Participated in the strategic planning commission to allocate a $150
million healthcare loan. Loan went to 14 new 120-bed hospitals for
required medical equipments.
- Provided onsite technical support and trained surgeons on IGS system
use (Image Guided Surgery) from each initial MRI/CT scans to surgery
planning through the complete 6 hours long brain surgeries.
- Innovative problem solver with focus on finding the root cause of
the problem. Create project plans, for short and long term solution that
ensures functionality, smooth operations flow and customer satisfaction.
- Approachable personality that creates comfortable level of
communications with coworkers and clients.
- Team minded leader that is focused on developing people.
- Creative mechanical and electrical design skills that focuses on
product to market thinking approach.
- Skilled in the use of metal lathes, mill machines, welders and broad
variety of mechanical prototyping machines and tools.
- Software: Microsoft Project, Word, Excel, Power Point, Access,
Macros and Outlook. Cadence Orcad Capture 16.3, FreePCB, Adobe photo shop 6, Autodesk AutoSketch
9, ExpressPCB, SimOLED, MicroArray Genome Imaging & Clustering Tool,
OpenOffice.org tools, CadSoft Eagle, Electronics work bench, Quick Book,
Omnify, Serena Version Manager, and VAI.
- Programming background: Visual Basic, VHDL, Borland Java, HTML,
Borland Delphi, Pascal and Assembly
- Familiar with: SciLab, MatLab, C, C++, LabView, AutoCad, SolidWorks,
Silicon Labs IDE, Ride7, PSpice, Agile, embedded micro-controller design
and Gerb Tool.
- The American Association for the Advancement of Science (AAAS) –
Member.
- Waukesha County Technical College CO-OP/Internship Program
Certificate of Appreciation: In recognition of service, inspiration and
guidance to students-trainees.
- Sultan F, DP Klemer and KM Oaks, "Instrumentation for
Small-Animal Capnometry," 31st Annual International Conference of the
IEEE Engineering in Medicine and Biology Society, Minneapolis, MN 2009
- Instrumentation for Small-Animal Capnometry - Patent Pending.
- Research work at the Cozzens & Cudahy Research Center [CCRC].
Main research work focused on OLED BioSensors, and diseases DNA detection.
2009 – 2010
- IT support for Mitchell Street
Association (Non-profit economic development organization) 2004 – 2009
- Bone Densitometers full product line training certificate - NORLAND (A CooperSurgical Company) 2003
- Distributor Training certificate on Image Guided Surgery (IGS)
products - BrainLAB,
Munich 2003
- FDA Design Control Training Certificate – Realistic Quality
Solutions 2011
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