Medical devices
FDA QMSRIEC 62304ISO 14971ISO 13485
Operate under client QMS; produce product-lifecycle artifacts alongside hands-on development.
Embedded systems consulting for regulated devices.
ODB Engineering specializes in full-stack embedded systems support, board bring-up, and hardware-rooted security; supporting complex and regulated products throughout the entire device lifecycle, from prototype to deployed fleet.
Services
- Embedded Linux platforms: Yocto-based, 3rd-party distros, or custom BSPs.
- ARM SoC and MCUs: i.MX, STM32, and Zephyr RTOS.
- Connected devices: Linux networking, personal-area networks (BLE/802.15.4), SDR/MANET radios.
- Hardware-rooted security: Secure boot/TPM integration, OTA architecture, and device lifecycle.
- EE design: Design reviews, hardware/software integration, and board-level debug.
- Product security: Design reviews, threat modeling, and compliance-aligned design.
- Regulatory: Support for medical, aerospace, and industrial product programs.
- Technical leadership on sustaining engineering and complex debug efforts.
- Staff augmentation and junior engineer mentorship.
Industries
Aerospace & defense
AS9100DISA STIGs IATT approvalATO planning
Technical support for aerospace production, platform hardening and compliance activities. ITAR-aware.
Industrial & Consumer IoT
IEC 62443-awareIoT Frameworks
Secure boot, signed OTA, and ruggedized fleet update patterns.
Greenfield projects
Early startupsR+D
Let's get ahead of the competition and build something new and valuable.
About
ODB Engineering is a one-person firm by design. Clients work directly with the engineer doing the work — no handoff to offshore teams, no account-manager layer.
- Principal-level work, principal-level ownership. Ego-free integration with client teams.
- Fluent across medical, aerospace, and industrial regulatory surfaces.
- Security is baseline, not an add-on.
- Engagements can succeed anywhere in the entire hardware/firmware/software system stack.
- Erie, Colorado. US-only workflows.
Principal
ODB Engineering is Andy — sole consultant and technical lead.
MS and BS in Biomedical Engineering from Marquette University. Andy's career in embedded systems spans medical devices, aerospace/defense, and consumer/industrial IoT. His prior experience includes 10+ years of full-time senior/principal positions at Urban Sky, Philips Respironics, Hunter Douglas, and ChemImage; additionally Andy has 10+ years of consulting experience with Garrett Technologies, Tensentric, and Delve.
He maintains expertise across the entire stack: from circuit design to firmware, from initial bring-up to secure cloud connectivity. He has been on both sides of the client/consultant relationship, and knows how to deliver in both contexts. AI-savvy, not AI-dependent. References and full CV are available upon request.
Outside of the lab, he enjoys music, reading, and hiking with friends and family: always searching for the optimal design and balance in engineering and in life.
Wisdom is experience, accumulated.
Contact
Erie, Colorado · Denver / Boulder metro
remote-first, on-site for hardware integrations
1099 subcontract · direct contract · prime-flow