Business Details
31 Years
experience
Trusted Product Design and Engineering Services
Founded in 1995, Expertise Engineering operates as an extension of our clients' engineering departments, specializing in product design and development across medical, consumer, and industrial markets. Our ISO 9001 and 13485-certified team of 12-15 mechanical, electrical, and software engineers leverages over 25 years of collective experience to deliver end-to-end solutions from conceptualization to production. With 7,000 square feet of lab and office space in San Diego, we provide expertise in embedded systems, PCBA design, plastic part development, and manufacturing tooling.Our collaborative approach combines deep technical knowledge with practical problem-solving to address complex challenges in medical device design, IoT systems, and consumer product development. We maintain a focused team structure that mirrors the engineering capacity of a $20M product company, enabling rapid project onboarding and execution. Our capabilities span RF systems, firmware programming, regulatory compliance, and cost-effective manufacturing solutions tailored to client needs.
Services
Mechanical Engineering
Electrical Engineering
Software & Firmware
Product Development
Medical Device Design
PCBA Design
Industrial Design
Manufacturing Tooling
Embedded Systems
IoT Solutions
Details
- Year established: 1995
Highlights and features
- 25+ years of product development experience across multiple industries
- ISO 9001 and 13485 certified engineering processes
- In-house team of 15 multidisciplinary engineers
- End-to-end support from concept to production
- Specialized expertise in medical device and IoT product development
Associations and certifications
- ISO 9001
- ISO 13485
Services
Mechanical Engineering
Our mechanical engineering team specializes in enclosure design, mechanism development, and sensor integration. With seven SolidWorks licenses and 3D printing capabilities, we create precision components for medical devices, consumer electronics, and industrial equipment. Our expertise in manufacturing processes ensures designs optimize for cost-effective production while maintaining functional integrity.
Electrical Engineering
We deliver complete PCB assembly solutions using Altium Designer for schematic capture and layout. Our engineers specialize in RF systems, power supplies, microcontroller integration, and wireless protocols like Bluetooth and WiFi. With three dedicated seats and extensive component libraries, we develop complex boards for medical devices, IoT applications, and industrial control systems.
Software & Firmware
Our firmware and software team develops embedded solutions for connected devices and industrial equipment. With expertise in microcontroller programming and radio integration, we create firmware for IoT devices, medical instruments, and consumer electronics. Our collaborative approach ensures seamless integration with mechanical and electrical components throughout the development process.
Medical Device Design
ISO 13485-certified for medical device development, we design surgical tools, diagnostic equipment, and implantable devices. Our team understands regulatory requirements and documentation standards, providing complete solutions from concept to production-ready designs. We specialize in complex plastic parts and disposable medical components requiring precision manufacturing.
Manufacturing Tooling
We develop custom tooling, fixtures, and test equipment to support production processes. Our engineers create molds for injection-molded plastics, assembly jigs, and automated testing systems. With expertise in both mechanical and electronic integration, we ensure tooling solutions meet production efficiency requirements while maintaining quality standards.
Questions
What engineering services do you specialize in?
We specialize in mechanical, electrical, and software engineering for product development across medical, consumer, and industrial markets.
Are you ISO certified?
Yes, we hold ISO 9001 and ISO 13485 certifications for quality management systems in general and medical device engineering.
What geographic areas do you serve?
While based in San Diego, we serve clients nationwide with local expertise in Southern California's medical device industry.
How many engineers are on staff?
We maintain a team of 12-15 multidisciplinary engineers including mechanical, electrical, and software specialists.
What product development stages do you support?
We provide full lifecycle support from concept and prototyping through production, including documentation and regulatory compliance.
Can you help with manufacturing tooling?
Yes, we design custom molds, fixtures, and test equipment to support efficient production of plastic components and electronic assemblies.
