Transform Your Product Concept into Manufacturing Reality in 90 Days or Less
Join 100+ companies and inventors who've rapidly converted ideas to market-ready products with our end-to-end engineering solutions
Certified Excellence
From Design Challenges to Manufacturing Success
Product development roadblocks cost medical, automotive, and consumer product companies millions in delays and redesign. Step 2 Engineering eliminates these barriers with our validated three-phase process that accelerates your path to market.
Regulatory Roadblocks
Complex compliance requirements lead to costly redesigns and market delays
Manufacturing Delays
Designs that aren't optimized for production cause timeline extensions and budget overruns
Cost Overruns
Inefficient material selection and design flaws lead to excessive production costs
Our Three-Phase Solution
Step 2 Engineering's proven process bridges the gap between concept and manufacturing, eliminating costly redesigns and accelerating your time to market.
- Regulatory-compliant designs from day one
- Manufacturing optimized to meet quality and cost targets
- Accelerated timelines with our in-house prototyping and testing resources
- Clear project milestones, careful management of scope, complete manufacturing documentation
Feasibility Assessment
2-4 weeks
Design & Validation
6-12 weeks
Manufacturing Transition
10-14 weeks
Key Engineering Services
Comprehensive engineering solutions delivered by experts with decades of industry experience
Electrical Housing with UL Compliance
Designed a UL-compliant smart outlet housing that met multiple safety standards while optimizing for manufacturability.
Silicone Encapsulated Electronics for Medical Testing
Developed medical-grade silicone encapsulated electronics for patient testing that led to a successful FDA-registered product.
Medical-Grade Silicone Rapid Prototyping
Created production-quality, medical-grade silicone prototypes when 3D printing couldn't deliver the necessary material properties.
IP67 Waterproof Electronic Housing Design
Designed a reusable IP67-rated waterproof housing with innovative gasket retention that maintains seal integrity after repeated opening.
CPSC-Compliant Children's Character Design
Designed and produced 80,000 CPSC-compliant, LEGO®-compatible character figures with zero quality issues or import problems.
Electrical Housing with UL Compliance
Design a smart outlet housing that complies with multiple safety standards including ANSI NEMA WD-6, UL 498, UL 60730, UL 514D, and UL 1310 while optimizing for injection molding and efficient assembly.
Successfully guided the customer through the certification process, resulting in final certification for the intended market. We provided expert support throughout the certification process, working with major testing labs to deliver efficient, positive outcomes.
Silicone Encapsulated Electronics for Medical Testing
Develop early-phase prototypes using ISO 10993-1 compliant materials for patient field testing, supporting both fundraising efforts and design refinement prior to final specification.
Multiple prototype versions were successfully produced, enabling the collection of key data needed to transition the design to a finished FDA-registered product. The final version is now commercially available on the market.
IP67 Waterproof Electronic Housing Design
Design a product housing that meets IP67 ingress protection standards, providing dust-tight sealing and water resistance up to 1 meter submersion, while allowing for repeated opening and closing.
Prototype testing has shown strong performance under simulated IP67 conditions. The design allows for repeated opening and closing without compromising seal integrity.
Industry Certifications
Our designs and processes meet the highest industry standards
We regularly provide compliant documentation and processes to clients who are using the ISO 13485 medical device quality management system.
Our processes and high quality documentation control will support your effort to be ISO 9001 compliant.
We support FDA Class II medical device development by understanding the requirements and delivering products capable of meeting these requirements.
We have extensive CE marking experience. Let us guide your certification process and take advantage of the efficiency we offer.
Eliminate safety certification roadblocks that delay product launches by months. Prevent the 35% cost increase typically associated with post-design safety modifications.
Design food-safe products that pass NSF certification on first submission. Avoid the 45-day average delay and costly materials rework of failed certifications.
Showing 6 of 6 case studies
Electrical Housing with UL Compliance
Design a smart outlet housing that complies with multiple safety standards including ANSI NEMA WD-6, UL 498, UL 60730, UL 514D, and UL 1310 while optimizing for injection molding and efficient assembly.
Successfully guided the customer through the certification process, resulting in final certification for the intended market. We provided expert support throughout the certification process, working with major testing labs to deliver efficient, positive outcomes.
Silicone Encapsulated Electronics for Medical Testing
Develop early-phase prototypes using ISO 10993-1 compliant materials for patient field testing, supporting both fundraising efforts and design refinement prior to final specification.
Multiple prototype versions were successfully produced, enabling the collection of key data needed to transition the design to a finished FDA-registered product. The final version is now commercially available on the market.
Medical-Grade Silicone Rapid Prototyping
Create high-quality, biocompatible silicone prototypes for patient field testing that meet hospital IRB requirements, when traditional 3D printing methods couldn't deliver the necessary material properties.
Delivered production-quality silicone parts with complex geometries on a short schedule. The customer remarked, 'These look like production parts,' after previous unsuccessful attempts with 3D printing.
IP67 Waterproof Electronic Housing Design
Design a product housing that meets IP67 ingress protection standards, providing dust-tight sealing and water resistance up to 1 meter submersion, while allowing for repeated opening and closing.
Prototype testing has shown strong performance under simulated IP67 conditions. The design allows for repeated opening and closing without compromising seal integrity.
CPSC-Compliant Children's Character Design
Design a 4-inch-tall character based on existing plush toys, adapted for injection molding with LEGO®-compatible features, while meeting CPSC regulations for children's products and tight cost targets.
Successfully produced 80,000 units used as premium collectibles for VIP passes at customer events, with on-time deliveries, zero quality complaints, and no import issues.
Automated Medical Device Cycle Tester
Design an automated testing solution to verify a revised medical product design after field failures due to cracking in a flexible PCB trace. Manual hand-washing tests were time-consuming and yielded inconsistent results.
The revised product configuration, verified through our automated cycle testing, achieved a >25% reduction in field failure rates with over 1,000 units deployed.
Need a Similar Engineering Solution?
Our team of experienced engineers can help you with your specific project challenges. Contact us today to discuss your requirements and how we can help you achieve your goals.
Our Engineering Expertise Includes:
- Regulatory Compliance (UL, CE, FDA, CPSC )
- Medical Device Design and Testing
- Silicone Prototyping and Production
- Injection Molding Design and Optimization
- Custom Test Equipment Design
"They have met all expectations."
Jan 30, 2025
Step 2 has provided great communication throughout the project, and continues to do so. Step 2 approaches projects with great attention to detail that surpasses expectations. I can count on Step 2 to provide timely responses to requests, and communicate their anticipated timelines and project opinions clearly.
– Medical Device Sales and Manufacturing
"I'm amazed by their depth of engineering knowledge and their experience in manufacturing and design."
Jan 27, 2025
Step2engineering was originally hired for spring calculation I was using in my prototypes. Matthew delivered extremely quick and advised me I needed a different type of spring for what I was trying to accomplish. He then recommended he provide me with some new design options to accomplish what I was trying to achieve in my pedal design. Matthew also informed me of a International Safety Standards Test required for the pedal if i sold it internationally which I am and they provided a design around this criteria.
– 8 Degree Pedal
Frequently Asked Questions
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