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.
About The Role
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.
Responsibilities
- 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.
- Support recruiting and development of future engineering talent.
- Collaborate cross-functionally across R&D, Quality, Manufacturing, Clinical, and Operations.
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
Requirements
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Systems Engineering, or related field required. Advanced degree preferred.
- 10+ years of experience in medical device or combination product development.
- Strong experience with electromechanical and/or software-enabled medical devices.
- Experience with wound care or drug delivery systems strongly preferred.
- Experience working with contract manufacturers and external engineering partners.
- Startup or small-company experience strongly preferred.
- Understanding of FDA GDP regulations and ISO 13485.
- Strong systems-level technical thinking.
- Excellent communication and leadership capability.
- Hands-on engineering mindset.
- Strong organizational and prioritization skills.
- Comfortable operating in ambiguous and rapidly evolving environments.
- Ability to independently drive technical execution.
- High-accountability builder mentality.
- Hands-on, driven work ethic and entrepreneurial spirit.
- Proficiency with Microsoft Office and technical presentation tools.
- Experience with CAD systems (SolidWorks preferred).
- Experience with eQMS and requirements/risk management platforms.
- Familiarity with ALM systems, statistical tools, and modern engineering collaboration platforms.
Our Benefits
- 100% of Health Insurance paid by OstealTx for Employee & Dependents
- Dental & Vision Insurance
- Short & Long Term Disability Insurance paid 100% by OstealTx
- 401k (Regular & Roth)
- Holiday Pay & PTO
- Competitive compensation: ($200,000 -$225,000) + Bonus + Equity
Skills Required
- Bachelor's degree in Mechanical, Biomedical, Electrical, Systems Engineering or related field
- Advanced degree
- 10+ years of experience in medical device or combination product development
- Strong experience with electromechanical and/or software-enabled medical devices
- Experience with wound care or drug delivery systems
- Experience working with contract manufacturers and external engineering partners
- Startup or small-company experience
- Understanding of FDA GDP regulations and ISO 13485
- Experience with IEC 60601, IEC 62304, ISO 14971, and Human Factors Engineering
- Proficiency with Microsoft Office and technical presentation tools
- Experience with CAD systems (SolidWorks preferred)
- Experience with eQMS and requirements/risk management platforms
- Familiarity with ALM systems, statistical tools, and modern engineering collaboration platforms
What We Do
Osteal Therapeutics is a privately-held, clinical-stage pharmaceutical company developing novel musculoskeletal therapeutics to treat orthopedic infections and their consequences.
