Dallas, Texas, United States · Hybrid
$200k–$225k/yr
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 Brea…
Skills: Product Development, Systems Engineering, Design Controls, Risk Management, Verification & Validation
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Lead the development and maturation of a software-enabled drug delivery platform, overseeing new product development and sustaining engineering. Drive technical execution of FDA-compliant design controls, risk management, and verification and validation activities.
Requires a Bachelor's degree in Engineering (Mechanical, Biomedical, Electrical, or Systems) and over 10 years of experience in medical device or combination product development. Must have strong expertise in electromechanical devices and a deep understanding of FDA GDP and ISO 13485 regulations.
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.
\nAbout The RoleOsteal 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.
Product Development & Technical Leadership
Cross-Functional Collaboration
Leadership & Team Development
Osteal Therapeutics is an Equal Opportunity Employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to protected characteristics such as race, color, religion, sex, national origin, age, disability, or veteran status.
Revolutionizing the treatment of orthopedic infection. Preserving Limbs. Preserving Lives
Osteal Therapeutics is a privately held, clinical-stage pharmaceutical company developing novel musculoskeletal therapeutics to treat orthopedic infections and their consequences.
Offices: Dallas, TX, US
Revolutionizing the treatment of orthopedic infection. Preserving Limbs. Preserving Lives
Osteal Therapeutics is a privately held, clinical-stage pharmaceutical company developing novel musculoskeletal therapeutics to treat orthopedic infections and their consequences.
Offices: Dallas, TX, US
