Andy Bordon Email & Phone Number

Lead contributor, managing cross-functional resources in developing bioburden analysis technology.▪ Leading validation testing of suction shoe pump and sample incubator of Soleil Rapid Bioburden Analyzer.▪ Saved $100k/yr through sustaining engineering of optical system of Eclipse Bacterial Endotoxins Testing (BET) Platform.▪ Innovated with statistical tolerance stack-up analysis in the development of mfg fixtures for optical components.

Broomfield, Colorado, United States

Designed, developed and sustained a large variety of mechanical systems for window fashions.▪ Independently developed lifting and control mechanisms for 2 product lines.▪ Designed, released and tooled 20 new components.▪ Coordinated with cross-functional teams to realize product launches (motorization, marketing, fabrication, tooling).▪ Successfully launched 3 products- $1M in market share.▪ Owned and maintained DHF materials.

Louisville, Colorado, United States

Provided expert mechanical engineering services to bring concepts to life. Designed and developed a dynamic range of products, within multiple industries, across a diverse customer base.▪ Developed mechanical, product and system concepts that satisfied customer requirements, transferred ideas into manufacturable products using a variety of low-to-mid volume manufacturing processes.▪ Fully developed prototypes, diligently documented to ensure high quality builds were delivered on time.▪ Supported multiple projects, balanced deliverables across several deadlines working in an Agile based JIRA environment.▪ Interfaced with customers to present options to solve challenging mechanical problems and design trade-offs.

Englewood, Colorado, United States

Scheduled and supported the planning and management of 7 injection mold overhaul projects.▪ Lead technical reviews analyzing design critical features, features critical to manufacturing assembly automation, part-inspection, risk analysis, and mold OQ/IQ/PQ of high volume (1M+/yr) class II medical devices.▪ Managed ECO packages (models, drawings, specifications, BOMs) related to new mold development.▪ Supported new product development by coordinating with cross-functional teams (new product development, operations, quality), providing modeling expertise, and offering technical insight (tolerance stack-up analysis, FEA) for molded parts.▪ Solved manufacturing problems related to molding, inspection, and automation issues- maintaining $2M revenue.▪ Business analysis: Organized and managed EOL activities, analyzed BOM structure, and executed ECOs to obsolete parent and child product codes.

Buffalo Grove, Illinois, United States

Managed research, development and sustainment of class II medical devices in the breast pump and nursing industry.▪ Lead sustaining engineering and new product development by driving conceptualization, design, prototyping, documentation, design verification, low volume manufacturing development, and validation.▪ Managed DMR and DHF change packages (drawings, models, specifications, BOMs, risk files, and procedures).▪ Developed test procedures, managing technicians throughout V&V activities of electromechanical breast pump.▪ Drove remediation activities- developing risk analysis, DFMEA, PFMEA and traceability matrices for 4 product lines.▪ Managed procurement of materials, components, and subassemblies from suppliers –international and domestic.▪ Coordinated with cross-functional teams to maintain project schedules, hitting key deadlines on time.

Lake Zurich, Illinois, United States

Developed a high volume, cost-saving apheresis disposable kit from conception through clinical trials.▪ Developed novel pressure sensing, interior in-line blood filtering, and hardware-disposable interface technology.▪ Expertly resolved technical challenges related to concept development, materials, design, prototyping, systems integration, verification, validation, manufacturing process development, inspection, sterilization and packaging.▪ Drove design activities- managing model and drawing packages, complex system assembly tolerance stack-up analysis, and leading cross-functional team formal design reviews. Verified analysis with extensive systems-level testing.▪ Independently defined component, subassembly and process acceptance criteria, specifications and V&V test protocols.▪ Developed manufacturing assembly processes- hot plate welding, ultra-sonic welding, and kit assembly line flow.▪ Managed procurement of materials, components, and subassemblies from suppliers –international and domestic.

Lake Forest, Illinois, United States

Worked with design engineers to design and execute studies of several prototype and on-market class II medical devices. ▪ Designed and implemented test procedures, meeting ISO 13485 and other regulatory test standards.▪ Documented test results following design traceability protocol and GDP.▪ Creatively adapted lab equipment to satisfy test equipment requirements (Instron, pressure and torque gauges, etc.).

Bachelor Of Science - Bs, Applied Mathematics, 3.56

Bachelor Of Science - Bs, Engineering Physics, 3.56