Director of Engineering

Osteal Therapeutics is a Dallas-based, privately held biotechnology company redefining the standard of care for life-altering orthopedic infections.

Osteal is hiring to launch NEXCHANGE KIT, a first-of-its-kind FDA Breakthrough Therapy for periprosthetic joint infection (PJI), a critical condition impacting 50,000 Americans annually. PJI currently lacks FDA-approved therapies and forces patients through grueling, months-long treatments with poor outcomes. Our disruptive technology transforms this journey by safely delivering high-concentration, broad-spectrum antibiotics directly to the infection site; reducing the treatment timeline from months to just seven days.

Powered by $137M in funding to date and a distinguished investor base that includes strategic partners Johnson & Johnson and Zimmer Biomet, we are advancing toward FDA approval and building the organization that will bring this therapy to patients in dire need.

We are looking for bold, relentless professionals who thrive in a “builder” environment. If you are driven by the opportunity to do work that genuinely matters — to be part of a cohesive and capable team striving to deliver the first on-label PJI treatment that promises to transform outcomes for tens of thousands of patients.

Osteal Therapeutics is seeking a Director of Engineering to lead the next phase of development and maturation of the company’s software-enabled drug delivery platform.

This role is intended for a technical engineering leader capable of driving product development execution within a fast-moving FDA-regulated startup environment.

The Director of Engineering will provide direct leadership across new product development, sustaining engineering, systems integration, design controls, risk management, and verification & validation activities associated with Osteal’s NEXCHANGE Irrigation System.

This role requires significantly more than traditional project management or people leadership. The ideal candidate will be a strong systems thinker, a highly capable technical contributor, experienced in FDA-regulated medical product development, comfortable operating across software and hardware boundaries, and capable of directly driving engineering execution. The Director of Engineering will work closely with Software Engineering, Regulatory Affairs, Quality Affairs, Manufacturing, Clinical, and Operations teams to improve and expand Osteal’s current product platform while supporting commercialization readiness and future product innovation.

Essential functions of the position include but are not limited to the following. Other duties may be assigned.

• Lead engineering execution associated with upgrading Osteal’s Fluid Management System and Wound Dressing Kit product platforms.
• Drive new product development initiatives from concept through commercialization.
• Assist sustaining engineering and product improvement activities for existing commercial-stage systems.
• Drive system-level design architecture, integration strategy, and engineering decision‑making.
• Ensure strong execution of FDA‑compliant design controls and engineering documentation.
• Support development and execution of verification & validation strategies.
• Collaborate closely with Software Engineering on system architecture, controls, alarms, integration, and reliability.
• Lead technical troubleshooting, root cause investigations, and field issue resolution.
• Support manufacturing supplier management and design transfer activities.

• Support technical documentation development for regulatory submissions and agency communications.
• Collaborate closely with Regulatory Affairs and Quality on DDF development, risk management, V&V, and change control activities.
• Lead engineering activities associated with IEC 60601, IEC 62304, ISO 14971, and Human Factors Engineering.

• Lead and mentor engineering team members.
• Help establish a high-performance engineering culture centered around accountability, technical rigor, and execution speed.
• Coordinate internal engineering resources and external development partners.
• Supp…