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Charles C.

Medical Device Mechanical Engineer | Injection Molding | DFM/DFA | GD&T | Engineering Drawings | ISO

Tseung Kwan O, Hong Kong

Global rank:

13,717 / 129,810

Skill pts: 5

2D & 3D Modeling Solidworks CAD Design Concept Design Engineering Design SolidWorks

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About

Mechanical Engineer and Medical Device R&D Leader with 20+ years of experience in medical device product development, mechanical engineering and manufacturing.
Extensive experience developing medical devices from concept design through manufacturing and production transfer.
Worked on a wide range of products including:
* Surgical instruments
* Disposable medical devices
* Dialysis systems
* Medical tubing assemblies
* Injection molded medical components

Strong experience working in ISO13485 regulated development environments, creating engineering designs and drawing packages suitable for manufacturing and quality system documentation.

My focus is helping companies create clear, manufacturable designs and engineering documentation that suppliers and production teams can use directly.
My goal is to deliver engineering designs and drawing packages that are clear, manufacturable and ready for production.

Experience

R&D Director XinWell Medical Technology Co.,Ltd · Full-time Jul 2018 – Present 7 yrs 9 mos Ningbo, Zhejiang, China * Manage 4 R&D team base on Shanghai, Ninbo and Changzhou over 80 engineers which focus on microinvasive surgery, gastroenterology department , Breathing anesthesia field involved active mechanical device and disposable products and have gotten 12 CE licenses and 5 NMPA licenses.

* Lead team completed innovative digital chest drainage system design, V&V, animal experiment and over 16 disposable products development and registration, such as biopsy forceps, suction catheter, breathing mask, ERCP series.
Interface with the different company’s engineering, sales & Marketing, operations, and quality teams among others, in support of common projects and overall company strategy；
Improve the process of new product development and integrate cross function team, and coaching and mentoring the engineers for the product development process；

* Develop and implement Engineering strategies for current and future product and technology development projects based on the company’s overall objectives and resources: Focus on medical device is a top priority

* Take a hands-on approach to leading the group engineering team with a focus on project planning and management, risk assessment and mitigation, staff development and customer satisfaction.
* Support the Sales & Marketing team and work directly with customers to identify product needs, application details, and product requirements and provide support and technical expertise to pre and post-sales teams as well as application engineering professionals.

* Plan and formulate engineering programs and organize project teams according to project requirements and priorities and requirements and applicable specification (industry standards and homologation requirements);

* Participate in and contribute to strategic discussions regarding products, markets, and technology developments.

* Lead and oversee product design reviews and provide applicable approval for design changes, specifications, and drawing releases among others per Spellman engineering product development processes. Ensure project execution is completed in a timely fashion within allotted project budget.
Ensure compliance with all Spellman and other governing security regulations
Technical Lead – Project Management Fresenius Medical Care · Full-time Mar 2015 – Jul 2018 3 yrs 4 mos Shanghai, Shanghai, China Responsible for new CAPD product (Pharmaceutical container closure, tubing system, secondary packaging and carton design) and PD accessory research and development follow PDP development procedure. Responsible for DHF, registration dossier, design verification &validation, manufacture process, design transfer and shipping study. Completed CAPD1.0 and CAPD2.0 project and launched in China market successfully.
Technical Lead Engineer Fresenius Medical Care · Full-time Jul 2015 – Feb 2016 7 mos Ogden, UT, United States Worked with America team on 6L APD product development in Ogden plant (US) and improve PD product technic on production line, improve product development procedure and manufacture process in Ogden US.
Lead global TIC team to formulate and implement the strategy with respect to new technical research and development of container and closure.
Technical leader Fresenius Medical Care · Full-time Jan 2014 – Jun 2015 1 yrs 5 mos Shanghai, Shanghai, China Lead team to completed HD product design and verification, new PD product design,manufactures process development and project management
Mechincal leader GE Healthcare · Full-time Jun 2005 – Jan 2014 8 yrs 7 mos Wuxi, Jiangsu, China  Lead mechanical team to work with cross function team on new product research and development, validation, design improvement, manufacture process development and project management. Launched new Ultrasonic bone density medical device on 2010.
 Responsible for new production line setting up and product transfer project. Worked with OEM supplier and US CFT member to build new production assembly line and new production line in GE for new product. Worked with global team to transfer the production line of X-ray medical device Bravo from US to China and leaded localization project to complete 60% parts localized.
 Worked with US team and visited Madison plant several times for new product design.
 As mechanical leader report to operation manager and is responsible for all mechanical design, lead mechanical engineer and work with electric team, software team and other cross function team.
R&D Engineer Leader Wellgain precision mold company · Full-time Mar 2003 – Jun 2005 2 yrs 3 mos Wuxi, Jiangsu, China  Working on the rear mirror and sunroof product research and development, design verification and validation. Released 2 model rear mirror products.
 Responsible for the production line setting up. Make development plan and coordinate R&D and manufacture to match whole project schedule. Lead cross function team and resource to complete one automatic production line of rear mirror building with budget controlling.
 As R&D project leader report R&D manager and work with cross function team.
Design Engineer Mingfang Auto-mobile parts Co.,Ltd · Full-time Jul 1996 – Mar 2003 6 yrs 8 mos Wuxi, Jiangsu, China  Working on mold, measurement and jig design and manufacture for Auto-mobile parts and appliance parts. Responsible for writing and releasing the manufacture technical files.
 Working on the project management of production line transfer from foreign to Wuxi plant.In the cases of production line of car seat & seat cover transfer from Taiwan to Wuxi which timeline problems could not catch up the schedule, decompose the task more detail and use project management tool to low the risk. Delivery the information to the technical team in time to settle, and track the settlements before communicating with the management team. Finally, the production line transfer is completed on time and produced product on Sep, 2002.
 As project leader report general manager and working closely with the cross function team and other co-workers.

Education

Jiangnan University Master, Wuxi China, Mechanical Engineering 2012 – 2014 Mechanical Engineering
Nanjing university Banchelor, Nanjing 1999 – 2003 Computer & Application
Nanjing University of Aeronautics and Astronautic Banchelor, Nanjing, Design and Manufacture of Die &Mould 1992 – 1996 Design and Manufacture of Die &Mould

Other experience

Manufacturing & Production Support * Design transfer to manufacturing

* Supplier technical communication

* Manufacturing process support

* Production problem solving
Injection Molding & Plastic Parts * Injection molded medical components

* Silicone and elastomer parts

* DFM / DFA optimization

* Mold design collaboration*
Medical Device Mechanical Design * Medical device assemblies

* Surgical instruments

* Disposable medical devices

* Medical tubing and connectors

Licenses & Certifications

PMP Certificate PMI Aug 2022 – Present
ISO13485 certification TUV Feb 2020 – Present
ISO14971 Riskmanagement BSI Apr 2018 – Present
Technical Design Review&Design for Six Sigma GE Healthcare Jun 2011 – Present
GD&T certification Tec-Ease, Inc Nov 2010 – Present