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Principal Engineer medical devices

Cincinnati, OH
April 08, 2016

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Michael Dolgin

Cincinnati, OH • 513-***-**** • •

Engineering Leader: Design, Analysis, Development of Reliable Medical Devices

Ph.D. • Certified Reliability Engineer (CRE) • Black Belt, Green Belt • Technical Project Consulting

Expert engineer, scientist, and consultant skilled in navigating FDA-regulated environments, assessing customer needs, and optimizing product specifications. Develop technical design and manufacturing specifications for new, low-cost medical devices. Analyze and model risk mitigation strategies at all project stages. Manage technical projects to exceed client expectations while balancing all stages of product development from market and IP analysis to product launch.

“Michael is a very creative engineer who delivers clever solutions to complex problems… with deep physics-based insights and solid computer modeling capabilities… achieving results within stated deadlines.” – Director of Research at AtriCure Inc.

Core Competencies

• FDA requirements and guidance for medical devices • Patent interpretation and Intellectual Property analysis

• Failure Mode and Effect Analysis (FMEA) • Fault Tree Analysis (FTA)

• Voice of Customer (VoC) • Design for Quality and Reliability • Quality Function Deployment (QFD)

• Lean Design • Design for Six Sigma • Design for Manufacturing

• Finite Element Analysis (FEA): mechanical and thermal, dynamic and static, linear and nonlinear

Career Path

Medical Engineering Consulting–Cincinnati, OH 2016–Present


Work with diverse client base to offer innovative solutions to “unsolvable” engineering problems by maximizing technical knowledge and application.

C.R.Bard–Mason, OH 2013–2016


Created low-cost, high-precision, and top-performing products while meeting and exceeding all specifications. Enhanced company IP: 9 invention disclosures, 3 patents pending.

Developed innovative conceptual design for urological guide-wire with doubled rigidity and lower cost without diameter increase, which was demonstrated at AUA 2015.

Designed next-generation urological sheath with surgeon-adjustable length at time of surgery.

Researched and proposed acquisition of Nanosecond Electro-pulse lithotripter with 90% reduction in manufacturing cost versus comparable instrument.

Analyzed/proposed hydrodynamic cavitations lithotripter project with optimal safety rating and decreased cost.

Atricure–West Chester, OH 2008–2013

SENIOR ENGINEER (2008–2010) / PRINCIPAL ENGINEER (2010 – 2013)

Developed and implemented multiple new RF ablation devices for low-invasive surgery that create robust transmural heart lesions.

Slashed manufacturing cost 30%, boosted manufacturability, and avoided complications.

Developed unique FDA-approved LAA Occlusion device: Improved performance, cut production costs 80%.

Engineered crio-ablation devices for low-invasive surgery with 70% enhanced flexibility.


Michael Dolgin, page 2 513-***-****

Career Path, continued…

3M Optical System Division–Cincinnati, OH 2003–2008


Completed thermal and mechanical design of micro-projector for cell-phone, featured on CNN in Top 3 innovative products out of 2,600 products at 2008 Consumer Electronics Show.

Developed cooling system for high-intensity LED illuminator, about 60 times more effective than comparable cooling systems. Demonstrated at CES and SID in 2006.

Designed First in world light emitting diode-based TV illuminator. Demonstrated at CES and SID in 2005.

Ethicon Endo Surgery–Cincinnati, OH 1997–2003


Conducted mechanical and thermal design/analysis of multiple products. Developed enhanced FEM model for analysis of staple forming for surgical staplers, assuring tissue closing reliability and staple forming accuracy.

Analyzed thermal model of ultrasonic scalpel, saving project development time 40% by shortening time required for design iteration and testing.

Collaborated to develop famous Mammotome Breast Biopsy System and Micromark II surgical marker.

Generated optical and thermal design of Trocar NGT Optiview.

Early Work History

SENIOR MECHANICAL ENGINEER, W.L. Gore and Associates (Phoenix, AZ) 1993–1997

Completed numerous equipment and product design projects. Influenced 300% productivity increase, slashed operation time 50x, and accelerated reliability testing.

SENIOR ENGINEER, Acoustic Imaging (Phoenix, AZ) 1992–1993

Developed transducers for 3-D ultrasound imaging.

MECHANICAL DESIGN ENGINEER, U.S. Precision Lens 1990–1992

Designed various fixtures and equipment for production of optical elements.

Education / Professional Development

Ph.D., Mechanical Engineering (1978) M.S., Mechanical Engineering (1971)

Leningrad Institute of Technology (Russia)

Theory of Solution of Inventive Problems, 1997–2016

“Solidworks” various classes, 2009–2015

Geometric Dimensioning and Tolerancing (GD&T), 2001–2013

Engineering Monte-Carlo modeling, 2012

Black Belt, Green Belt, 1998–2011

Certified Reliability Engineer (CRE), 2002


Computer proficiency: Solidworks • ProE • Comsol • Mathcad • Molgflow • Word • Excel • Powerpoint

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