Design Verification Engineer - Embedded Systems (Sr. or Principal level)

Osteal Therapeutics; Dallas (TX); On-site; USD 110,000 - 150,000; Full time

Job summary

Osteal Therapeutics is seeking a hands-on Design Verification Engineer for its innovative medical devices. The role involves establishing verification testing protocols and conducting automated tests while ensuring compliance with essential medical device regulations. Ideal candidates will have a strong background in embedded systems and medical-device verification, contributing to the acceleration of product development in a dynamic environment.

Qualifications

• 5+ years embedded medical-device V&V with FDA-cleared or CE-marked product experience.
• Fluent in reading C firmware and PCB layouts.
• Experience in automated test frameworks.

Responsibilities

• Architect and design Automated Test Fixture (ATF) and test methods.
• Develop automated V&V deliverables including test plans and protocols.
• Ensure compliance with relevant safety standards (IEC 62304, ISO 13485).

Skills

Structured problem-solving

Python-based automation

Communication

Education

BS/MS in Electrical, Computer, or Biomedical Engineering

Tools

Oscilloscopes

Logic analyzers

Multimeters

Power analysis tools

Job description

Design Verification Engineer - Embedded Systems (Sr. or Principal level)

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Design Verification Engineer - Embedded Systems (Sr. or Principal level)

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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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

  Pharmaceutical Manufacturing

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