Osteal Therapeutics
Design Verification Engineer - Embedded Systems (Sr. or Principal level)
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The Design Verification Engineer will develop automated test infrastructures for medical devices, ensuring compliance and conducting verification and validation, while collaborating on design and continuous improvements.
Design Verification Engineer - Embedded Systems (Sr. or Principal level)
Job Status: Full Time Exempt
Reports To: Head of Software Engineering
Amount of Travel Required: Up to 10%
Location: Dallas, TX
Work Schedule: Full-time
Positions Supervised: None
Osteal Therapeutics:
Osteal Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a novel pipeline of combination therapies for orthopedic infections and their consequences. Our lead investigational candidate, VT-X7 was granted Orphan Drug, FastTrack and Qualified Infectious Disease Product designations by the FDA and is currently in late-stage clinical trials for the treatment of Periprosthetic Joint Infection (PJI). With a robust pipeline of additional indications and therapeutic candidates, we anticipate rapid and sustained growth.
Position Summary:
We are seeking a hands-on Design Verification Engineer to own hardware-in-loop (HIL) and automated test infrastructure for a next-generation medical device. You will establish test plans, methods, protocols, and record results of verification testing into reports. You will architect an Automated Test Fixture (ATF), build Python-based regression suites, and drive IEC 62304/IEC 60601 compliant V&V. Expect to work with STM32 MCU boards, load cells, vacuum pumps, and valves while embedding your work into CI/CD pipelines (GitHub Actions, Jenkins, NI TestStand, Robot Framework, pytest). Ideal candidates blend medical-device experience and the ability to design test fixtures and thrive in a fast-moving environment.
Essential Functions:
Essential functions of the position include but are not limited to the following. Other duties may be assigned.
· Architect, design, and bring up the ATF (fixture hardware + PC control software)
· Develop automated unit, integration, static (Coverity, clang-tidy), dynamic, and HIL test suites using frameworks that are suitable for integrating into CI/CD for fast regression
· Author and execute V&V deliverables—test plans, protocols, trace matrices, reports—covering firmware, PCBAs, sensors, and electromechanical subsystems
· Maintain requirements, risk, and test traceability using an Application Lifecycle Management platform
· Lead root-cause analysis and partner with design engineering on corrective actions
· Champion continuous improvement of verification workflows, tooling, and metrics dashboards
· Participate in code reviews, problem evaluation boards, and change-impact analyses
· Ensure compliance with IEC 62304, IEC 60601-1/-8, ISO 14971, ISO 13485, and FDA 21 CFR 820 design controls
Position Qualifications:
Experience and Education
· BS/MS in Electrical, Computer, or Biomedical Engineering (or related)
· 5+ years embedded medical-device V&V with at least one FDA-cleared or CE-marked product
· Demonstrated ATF design and Python-based automation or other test frameworks
· Fluent in reading C firmware, schematics, and PCB layouts for ARM Cortex M0/M3/M4 based systems
· Working with different software architectures and familiarity with I2C, SPI, CAN, UART, USB, and similar.
· Hands-on with oscilloscopes, logic analyzers, solder rework, multimeters, and power analysis tools
· Prior ownership of ALM/requirements management (Polarion, Jama, Helix ALM, Matrix)
Skills and Abilities
· Structured problem-solver who communicates clearly to technical and non-technical stakeholders
· Self-directed, able to juggle multiple priorities in a fast-paced R&D environment
The Design Verification Engineer will be instrumental in accelerating our product’s path to market by delivering robust, repeatable, and audit-ready verification infrastructure. If you are passionate about medical devices and excel at transforming complex test challenges into elegant automated solutions, we invite you to apply and help reduce infection-related complications for joint-replacement patients.
Top Skills
Can
Github Actions
I2C
Jenkins
Ni Teststand
Pytest
Python
Robot Framework
Spi
Uart
Usb
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