Embedded Systems Engineer
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 Systems Engineer with a strong electrical engineering foundation and interest in mechanical integration to join our R&D team developing next-generation medical devices. You’ll design, build, and test embedded systems for cutting-edge medical devices with responsibilities spanning firmware, electronics, and electromechanical subsystems. Reporting to the Head of Software Engineering, this engineer will collaborate closely with mechanical engineers, systems engineers, and test teams to deliver safe, effective, and innovative medical technologies in alignment with regulatory standards. The ideal candidate combines deep technical expertise with hands-on prototyping skills, a systems-thinking mindset, and strong communication abilities. Ideal candidates are tinkerers, builders, and cross-disciplinary problem solvers who thrive in a lab environment and enjoy owning the full system.
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 hardware/software systems for Class II/III medical devices.
· Develop and test analog and digital circuits, including power management, sensors, actuators, and communications interfaces.
· Write and validate embedded software/firmware in C/C++ for microcontrollers or SoCs (e.g., STM32, TI, Nordic) with real-time or low-power constraints.
· Work collaboratively with mechanical, software, and process engineers to integrate electronics into durable and disposable device form factors.
· Design and build prototypes and custom test fixtures to evaluate performance, reliability, and safety of electronics and software subsystems.
· Support design verification and validation (DV&V) activities, including authoring protocols, collecting test data, performing failure analysis, and compiling reports.
· Ensure compliance with applicable medical device regulations and standards, including IEC 60601, ISO 13485, ISO 14971, and IEC 62304.
· Conduct risk analyses (FMEA, software hazard analysis) and support remediation actions during design iterations.
· Participate in design reviews and contribute to system-level architecture and requirements development.
· Assist in supplier selection, specification, and technical interface for electronic components or subsystems.
· Maintain detailed design documentation in accordance with FDA design controls (21 CFR 820) and the design control waterfall process.
Position Qualifications:
Experience and Education
·Bachelor’s or Master’s degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, or a related field.
·Minimum 5 years of experience in embedded systems development.
·Strong problem-solving skills with a systems-thinking mindset and the ability to debug hardware/software interactions.
·Self-directed and accountable; capable of managing multiple priorities in a fast-paced R&D environment.
·Strong written and verbal communicator able to translate complex technical issues for diverse audiences.
·Team player who thrives in cross-functional settings and actively contributes to group problem solving.
·Familiarity with medical device regulatory and documentation requirements.
·Proficiency in software development methodologies and tools (e.g., Agile, Git, JIRA).
·Strong understanding of software architecture, design patterns, and best practices.
·Familiarity with software verification and validation processes for medical devices.
·Knowledge of FDA regulations and standards applicable to medical device software (e.g., IEC 62304).
Skills and Abilities
· Excellent organizational and communication skills.
· Hands-on, driven work ethic and entrepreneurial spirit.
·Strong decision-making skills
·Ability to work independently and ability to manage multiple priorities.
· Willing and able to travel as needed (typically 10-15%).
The Embedded Systems Engineering will play a crucial role in advancing our drug delivery systems and future technologies through innovative system solutions while ensuring compliance with regulatory requirements and maintaining high standards of software quality. If you are passionate about medical devices and have the required qualifications, we invite you to apply and join our team dedicated to making a difference in reducing mortality, morbidity, and the cost of care associated with musculoskeletal infections.
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