The Role
Lead the architecture, development, and verification of safety-critical firmware for drug-delivery devices, ensuring compliance with medical device regulations and driving software quality.
Summary Generated by Built In
Embedded Software Engineer (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 Embedded Software Engineer, at a Senior or Principal Level to lead the architecture, development, and verification of safety‑critical firmware for our next‑generation drug‑delivery devices. Your primary responsibility will be embedded software: designing real‑time C/C++ code for microcontrollers (e.g., STM32), ensuring compliance with IEC 62304, and driving software quality through rigorous testing and documentation. You will work closely with electrical, mechanical, and systems teams. The ideal candidate possesses deep embedded software expertise, a passion for medical device innovation, and the ability to mentor others while delivering high‑quality code in a regulated environment.
Essential Functions:
Essential functions of the position include but are not limited to the following. Other duties may be assigned.
· Architect, design, and implement embedded firmware in C/C++ for Class II/III medical devices.
· Develop and test analog and digital circuits, including power management, sensors, actuators, and communications interfaces.
· Design real‑time software using bare‑metal, state‑machine, or RTOS (e.g., FreeRTOS) paradigms, including bootloaders, low‑level drivers, control loops, and communication protocols (USB, BLE, CAN, Ethernet).
· Generate and maintain software design documentation—requirements, architecture, risk controls, and traceability—in accordance with IEC 62304 and FDA 21 CFR 820 design controls.
· Plan and execute unit, integration, and system‑level software verification & validation, including automated test frameworks and hardware‑in‑the‑loop setups.
· Lead code reviews, static/dynamic analysis, and continuous integration pipelines to enforce coding standards, defensive programming, and regression testing.
· Participate in software risk management (software FMEA, cybersecurity analysis) and implement mitigation strategies.
· Collaborate with hardware and systems teams on board bring‑up, driver integration, and providing firmware expertise.
· Support internal and external audits by presenting software lifecycle evidence and maintaining complete, current design history files.
· Mentor junior engineers and champion a culture of quality, continuous improvement, and knowledge sharing.
· Stay abreast of emerging embedded software techniques, medical device regulations, and cybersecurity guidance.
Position Qualifications:
Experience and Education
· Bachelor’s or Master’s degree in Computer Engineering, Electrical Engineering, Biomedical Engineering, Computer Science, or a related discipline.
· Senior level: 7+ years; Principal level: 10+ years of embedded software development for safety‑critical or regulated products, with demonstrated ownership of full software lifecycle deliverables.
· Expertise in C/C++ programming for ARM Cortex‑M or similar MCUs, including low‑level driver development and optimization for power, memory, and performance.
· Hands‑on experience with RTOS integration, interrupt‑driven design, and timing‑critical control algorithms.
· Proven track record generating software documentation and V&V evidence compliant with IEC 62304, ISO 14971, and FDA QSR.
· Proficiency with version control (Git), issue tracking (JIRA), and CI/CD tools (GitHub Actions, Jenkins).
· Experience with unit‑test frameworks (Ceedling/Unity, CMock, CppUTest) and static analysis tools (Coverity, C‑STAT, PC‑lint, or equivalent).
· Strong problem‑solving skills, including use of oscilloscopes, logic analyzers, and debuggers (JTAG/SWD) to troubleshoot firmware‑hardware interactions.
Skills and Abilities
· Clear and concise communicator capable of conveying complex technical concepts to cross‑functional teams and executives.
· Organized, detail‑oriented, and able to balance multiple priorities in a fast‑paced R&D environment.
· Proactive mentor who fosters a culture of excellence, continuous learning, and constructive feedback.
· Self‑directed, hands‑on engineer who thrives on delivering reliable products that improve patient outcomes.
Computer Software / Programs
· Languages: C, C++, Python or Bash scripting for tooling
· IDEs/Toolchains: STM32CubeIDE, Keil MDK, IAR EWARM, SEGGER Embedded Studio, GNU Arm
· RTOS & Middleware: FreeRTOS, ThreadX, Zephyr, lwIP, USB Device/Host stacks
· DevOps & QA: Git, GitHub Enterprise, GitLab, Jenkins, Coverity
· Test Automation: Unity, CMock, Pytest, TestStand and Labview
The Embedded Software Engineer will play a pivotal role in delivering reliable, safe, and efficient firmware that advances our drug‑delivery platforms while meeting the highest standards of quality and regulatory compliance. If you are passionate about embedded software and driven to improve patient outcomes, we invite you to apply and join our mission to reduce the burden of musculoskeletal infections.
Top Skills
Bash
C
C++
Ceedling
Cmock
Coverity
Freertos
Git
Git
Jenkins
Python
Stm32
Unity
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The Company
What We Do
Osteal Therapeutics is a privately-held, clinical-stage pharmaceutical company developing novel musculoskeletal therapeutics to treat orthopedic infections and their consequences.
