Re:Build’s strategically positioned facilities across the U.S. bring design, engineering, and manufacturing closer to your operations. Strategic locations across the U.S. enable faster collaboration, reduced lead times, and localized support, backed by nearly 1 million square feet of advanced manufacturing capacity and more than 1,200 technical experts.
Validate product concepts and technology feasibility to de-risk early-stage investment decisions before committing significant engineering resources.
Define system architecture that balances performance requirements with regulatory constraints, manufacturability, and scalability.
Execute detailed engineering design with cross-functional integration to meet specification requirements while maintaining design control and traceability.
Verify design outputs against specifications through structured testing protocols that satisfy regulatory requirements and quality standards.
Integrate subsystems into functional platforms with validated interfaces, documented verification, and full design transfer readiness.
Validate complete systems against user needs and regulatory requirements to demonstrate production readiness and market viability.
Develop validated manufacturing processes with documented procedures, controls, and capability studies to support regulatory submissions.
Scale from development to production-ready operations with qualified equipment, trained workforce, and compliant quality systems.
Execute production verification runs to validate process capability, quality systems, and manufacturing readiness before volume commitment.
Scale production volume systematically while maintaining process control, quality standards, and on-time delivery performance.
Deliver consistent production output with maintained quality standards, regulatory compliance, and supply chain reliability.
Drive ongoing optimization through data analytics, CAPA systems, and Lean manufacturing to reduce cost and improve performance.
Validate product concepts and technology feasibility to de-risk early-stage investment decisions before committing significant engineering resources.
Define system architecture that balances performance requirements with regulatory constraints, manufacturability, and scalability.
Execute detailed engineering design with cross-functional integration to meet specification requirements while maintaining design control and traceability.
Verify design outputs against specifications through structured testing protocols that satisfy regulatory requirements and quality standards.
Integrate subsystems into functional platforms with validated interfaces, documented verification, and full design transfer readiness.
Validate complete systems against user needs and regulatory requirements to demonstrate production readiness and market viability.
Develop validated manufacturing processes with documented procedures, controls, and capability studies to support regulatory submissions.
Scale from development to production-ready operations with qualified equipment, trained workforce, and compliant quality systems.
Execute production verification runs to validate process capability, quality systems, and manufacturing readiness before volume commitment.
Scale production volume systematically while maintaining process control, quality standards, and on-time delivery performance.
Deliver consistent production output with maintained quality standards, regulatory compliance, and supply chain reliability.
Drive ongoing optimization through data analytics, CAPA systems, and Lean manufacturing to reduce cost and improve performance.
User-centered medical device design combining industrial design, human factors analysis, and rapid prototyping to accelerate concept validation, enhance usability, and reduce development risk from initial feasibility through design freeze.
Safety-critical embedded software, firmware, and automation system development for medical devices, diagnostic equipment, and life sciences platforms. Featuring real-time systems expertise, diverse OS support (Embedded Linux, FreeRTOS, MQX/QNX), industrial automation integration, and rigorous validation processes to deliver reliable, hardware-integrated solutions for complex therapeutic and analytical systems.
Comprehensive verification and validation services including multi-physics simulation (fluidic, structural, thermal, electrical), sophisticated prototype testing, FEA, CFD analysis, and design-for-manufacturing optimization. From prototype validation through regulatory documentation support, we ensure medical devices meet FDA, ISO 13485, and MDR requirements for safety, efficacy, and market clearance.
Manufacturing scale-up and production line development for medical and life sciences. From clinical trial volumes through commercial scale, we design, build, and validate ISO Class 7 cleanroom environments, automated assembly systems, and inspection equipment to support regulatory submissions and enable seamless transition to full-rate production with complete traceability.
ISO Class 7 Clean Room
Years of ISO 13485 Expertise
Medical Products Developed
Quality & Compliance Certifications
Elevate your healthcare solutions with precision engineering that meets the highest industry standards. Partner with us to accelerate medical innovation while ensuring patient safety, regulatory compliance, and product reliability.
Core Competencies: Precision Machining | Metal Forming & Fabrication | Aerostructures, Components, & Kitting | Thermoplastic Composites
Address: 980 Jaycox Road, Avon, OH 44011
Core Competencies: Lightweight, Structural Thermoplastic Composites
Address: 5850 E 56th Avenue, Commerce City, CO 80022
Core Competencies: Aerospace Design, Analysis, and Testing | Skunk Works Division
Address: 24 Inverness Place E, Suite 200, Englewood, CO 80112 | 635 E. 52nd Avenue, Suite 200, Denver, CO 80216
Core Competencies: Re:Source Center | Wire Harness Design
Address: 161 Worcester Road, Suite 606, Framingham, MA 01701
Core Competencies: Industrial Design | Product Engineering | Electromechanical Assembly of Complex Systems | Wire Harness Manufacturing
Address: 3400 Tech Circle, Kalamazoo, MI 49006
Core Competencies: Software | Data Analytics | AI | ML
Address: 707 Wilshire Boulevard, Suite 5050, Los Angeles, CA 90017
Core Competencies: Industrial Equipment Automation
Address: 7 Crows Nest Circle, Unit 101, Merrimack, NH 03054
Core Competencies: Battery Solutions | Product Assembly | High-Volume Manufacturing
Address: 12th Street, Building 225, New Kensington, PA 15068
Core Competencies: Embedded Software & Controls
Address: 777 Canal View Boulevard, Suite 200, Rochester, NY 14623
Core Competencies: Thermoset Composites
Address: 485 Lakeshore Parkway, Rock Hill, SC 29730
Core Competencies: Chemical Process Engineering | Equipment Design & Fabrication
Address: 50 High Tech Drive, Rush, NY 14543
Core Competencies: Engineering | Prototyping | Medical Consumables
Address: 187 Ballardvale Street, Suite B210, Wilmington, MA 01887
Re:Build Manufacturing’s leadership is unified in its purpose: build a better future over the long term for the company’s customers, employees, partners, communities, and stakeholders through a new model of industrialization.
Built on Expertise
Our strength isn’t just in our facilities or technology—it’s in our people. Across the United States, over 1,200 team members bring deep expertise, diverse perspectives, and a shared commitment to solving complex manufacturing challenges. With more than 400 engineers supporting manufacturing, engineering, and product development, we tackle problems that demand both technical depth and collaborative problem-solving.
Imagination sparked our vision. Expertise drives our execution. But The Re:Build Way defines who we are.
Building sustainable American industry takes more than bold ideas and technical know-how. It requires a foundation of principles we live by every single day. The Re:Build Way is a set of 16 principles that guide every decision we make, especially the difficult ones.
When we choose safety over speed, when we pursue partnerships built on mutual benefit, when we invest in our people’s long-term growth, that’s The Re:Build Way in action.
