Nicholas Bailey, P.E. Email & Phone Number

Cincinnati, Ohio, United States

• A highly skilled and experienced engineer with a strong background in developing innovative solutions, particularly in the field of medical devices, consumer products, and industrial equipment.
• Led the development of design concepts for 10+ medical devices, delivering inventive and high-quality engineering solutions.
• Created detailed CAD models of parts and assemblies efficiently and developed comprehensive product documentation to support high-quality production.
• Played a key role in research and brainstorming, often leading these initiatives to foster creative problem-solving.
• Defined and drove the design for manufacture (DFM), design for assembly (DFA), and design for quality (DFQ).
• Orchestrated advanced engineering modeling, simulation, and analysis to support achieving product requirements.

Cincinnati, Ohio, United States

• Engineering lead focused on technical challenges and developing complex mechanisms.
• Collected, organized, and analyzed design inputs, including “voice of customer” data from key opinion leaders.
• Supported design research and human factors engineering studies through statistical analysis and user interviews.
• Conducted hands-on experimental work to evaluate device prototypes, demonstrate feasibility, and ensure commercial viability, applying statistical methods and valid scientific test methods.
• Delivered prototypes and documentation to meet client and user requirements.
• Mentored team members on GD&T, tolerance analysis, process control, and engineering statistics through formal training courses.

Cincinnati, Ohio

• Member of team preparing product for clinical trials and design verification.
• Technical lead responsible for completing platform tolerance analysis to ensure product functions and meets performance requirements.
• Conducted engineering studies verifying design intent with mechanical test systems and 3D printed fixtures.
• Aided manufacturing engineers with updated clinical manufacturing equipment and processes.
• Team’s expert on the product dFMEA and risk control process.
• Manage and mentor co-op students through various development activities including design, testing, analysis, and quality control.

Cincinnati, Ohio

• Technical leader tasked with producing minimally viable products from conception through verification and validation. Utilizing microfluidics and mechanical engineering concepts to innovate new technologies to solve.
• Lead critical research projects aimed at developing high quality wearable sensors for the medical industry through risk management, resourcing, and microfluidic expertise.
• Evaluate fluidic channel physics with COMSOL to identify failure points and functionality.
• Coordinate four teams through technology sprints to deliver platform demonstrations to improve company valuation.
• Create and innovate technologies to improve upon base wearable technology.
• Execute studies based on a hypothesis to drive data based conclusions and understanding.

Cincinnati, OH

• Designed tests, devices, and processes to meet client specifications as a part of a larger medical device development plan.
• Aided the designing and developing for over 6 devices a week based on client needs.
• Conducted mechanical and tissue tests to verify device functionality.

Patient Matched Implants Department

• Collaborated with surgeons and engineers globally to design over 100 patient matched implants and custom instruments with strict timelines.
• Improved department efficiency by implementing PLM software and processes.
• Solved unique surgical complications with novel solutions using mechanisms from outside medical devices.
• Compiled patient case proposals and FDA submission forms.
• Created engineering drawings and composed manufacturing instructions for vendors and manufacturing floor.
• Advanced additive manufactured product through verification and validation testing.

Warsaw, Indiana

• Integral Member of the Foot & Ankle Product Team
• Lead engineer for instrument project, guiding project team through the design control process.
• Participated on multidisciplinary team consisting of regulatory, quality, and manufacturing.
• Responsible for designing quality control gauges and overlays to ensure proper device manufacturing.
• Redesigned, validated, drafted, and manufactured current instruments to fit specific surgeon requirements
• Constructed and archived verification testing for Design History File.

Cincinnati, OH

Head coach of a JV lacrosse team at Elder High School.

Cincinnati, Ohio Area

Cincinnati, Ohio

• Member of research team and responsible for proving concept feasibility thru Technical Design Review 1 and hand off to product development.
• Collaborated on designs and equations to develop Instron test methods to evaluate new device concepts. Continued to iterate test methods as concepts evolved.
• Responsible for executing test methods, collecting, analyzing, and presenting data to group to drive concept iterations.
• Authored detailed Engineering Reports to document concept evaluation and test method development.
• Independently performed literature research to determine feasibility of alternate use of existing technology.
• Modeled a device concept in SolidWorks from rough hand formed models developed in a cadaver lab.

Master'S Of Engineering, Biomedical/Medical Engineering

Bachelor Of Science (Bs), Biomedical/Medical Engineering