Ceylan Guclu
Combination Product Design Control Business Process Owner (BPO) at Amgen | Los Angeles Metropolitan Area
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Ceylan Guclu serves as the Combination Product Design Control Business Process Owner (BPO) at Amgen, where she leverages her extensive background in electrical engineering and healthcare diagnostics to drive innovation and compliance in the development of combination products. With over 20 years of experience in the diagnostic healthcare industry, Ceylan has honed her expertise in product development processes, project management, and Six Sigma methodologies, holding the prestigious title of Master Black Belt. Her role involves leading the improvement and maintenance of Combination Product Design Control Standard Operating Procedures, ensuring adherence to regulatory standards such as 21 CFR 820 and ISO 13485.
Ceylan's responsibilities extend to representing Amgen during both internal and external audits, where her deep understanding of design control processes and regulatory requirements plays a crucial role in maintaining the company’s commitment to quality and safety. She is also actively involved in mentoring teams on Six Sigma projects, fostering a culture of continuous improvement and operational excellence. Her technical skills in biomedical engineering, FMEA, and hardware diagnostics, combined with her innovative mindset—evidenced by seven awarded patents—position her as a key contributor to Amgen's mission of advancing healthcare solutions. Ceylan's multifaceted expertise not only enhances product reliability and usability but also drives strategic initiatives that align with the company’s goals in the rapidly evolving landscape of medical devices and diagnostics.
Combination Product Design Control Business Process Owner (BPO) at Amgen in January 2019 to Present
Six Sigma MBB / Principal Systems Engineer at Amgen in July 2015 to January 2020
Six-Sigma MBB, Sr. Staff R&D Systems Engineer at Siemens Healthcare in August 2006 to July 2015
MR Systems Engineer/Six Sigma MBB at GE Healthcare in January 1997 to January 2006
Post-Doctoral Researcher at UC Irvine Medical Center in January 1995 to January 1997
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Six Sigma
MRI
Medical Imaging
Medical Devices
Design Control
R&D
Cross-functional Team Leadership
DICOM
Systems Engineering
Biomedical Engineering
X-ray
FMEA
ISO 13485
Matlab
Hardware Diagnostics
Project Management
FDA
Product Development
Mentoring
People Development
Usability Engineering
Electromagnetics
Immunoassays
Control Engineering
Diagnostics
Molecular Diagnostics
User Experience Design
kPCR
Robust Optimization
Robust Test Design
Medical Diagnostics
Failure Mode and Effects Analysis (FMEA)
Research and Development (R&D)
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Discover more about AmgenWhat is Ceylan Guclu email address?
Email Ceylan Guclu at [email protected]. This email is the most updated Ceylan Guclu email found in 2026.
How to contact Ceylan Guclu?
To contact Ceylan Guclu send an email to [email protected].
What company does Ceylan Guclu work for?
Ceylan Guclu works for Amgen
What is Ceylan Guclu's role at Amgen?
Ceylan Guclu is Combination Product Design Control Business Process Owner (BPO)
What is Ceylan Guclu's Phone Number?
Ceylan Guclu's phone (**) *** *** 377
What industry does Ceylan Guclu work in?
Ceylan Guclu works in the Biotechnology Research industry.
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