Baris Denizer
Design Assurance Manager at Abbott | St Paul, Minnesota, United States
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As the Design Assurance Manager at Abbott, Baris Denizer plays a pivotal role in ensuring the successful launch of innovative medical devices by leveraging his extensive expertise in design controls and regulatory compliance. With a keen understanding of customer needs, Baris leads a dedicated team of design assurance engineers, overseeing thirteen critical projects that encompass design changes, EUMDR and FDA submissions, and the qualification of new materials and suppliers. His proficiency in Human Factors Engineering, particularly in alignment with ANSI/AAMI HE75:2013 and IEC 62366 standards, ensures that user-centered design principles are integrated into every phase of product development.
Baris's technical acumen extends to statistical process control and measurement system analysis, which he employs to enhance manufacturing processes and drive continuous improvement. His leadership in conducting thorough root cause analysis and failure modes effects analysis (FMEA) has been instrumental in identifying potential risks early in the design phase, thereby safeguarding product quality and compliance. Additionally, Baris's experience with corrective and preventive actions (CAPA) and validation processes ensures that Abbott's medical devices not only meet but exceed industry standards.
Through his strategic decision-making and collaborative approach, Baris fosters a culture of innovation and excellence within his team. His commitment to navigating the complex regulatory landscape empowers Abbott to bring safe and effective medical devices to market, ultimately improving patient outcomes and enhancing the company's reputation as a leader in the healthcare industry.
Design Assurance Manager at Abbott in January 2023 to Present
Staff Design Assurance Engineer at Abbott in June 2021 to January 2023
Principal Design Assurance Engineer at Olympus Corporation of the Americas in October 2017 to June 2021
Sr. Design Assurance Engineer at Beckman Coulter in March 2014 to October 2017
Quality Assurance Engineer II at Boston Scientific in March 2012 to March 2014
Quality Assurance Engineer at STIHL Inc. in June 2011 to March 2012
Quality Systems Engineer at STIHL Inc. in December 2008 to June 2011
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Medical Devices
FMEA
SPC
Root Cause Analysis
Manufacturing
Continuous Improvement
CAPA
Injection Molding
Polymers
Composites
Validation
Decision-Making
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Discover more about AbbottWhat is Baris Denizer email address?
Email Baris Denizer at [email protected]. This email is the most updated Baris Denizer email found in 2026.
How to contact Baris Denizer?
To contact Baris Denizer send an email to [email protected]. (updated on September 13, 2024)
What company does Baris Denizer work for?
Baris Denizer works for Abbott
What is Baris Denizer's role at Abbott?
Baris Denizer is Design Assurance Manager
What is Baris Denizer's Phone Number?
Baris Denizer's phone (218) ***-*314
Baris Denizer Email Addresses
Baris Denizer Phone Numbers
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