About 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.
ResponsibilitiesEssential functions of the position include but are not limited to the following. Other duties may be assigned.
Product Development & Technical Leadership
- 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.
Cross-Functional Collaboration
- 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.
Leadership & Team Development
- 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.
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.
Preferred Qualifications
- 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.
Computer Software / Programs
- 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
