Director of Engineering

Osteal Therapeutics

Director of Engineering at Osteal Therapeutics driving product development in a fast-moving FDA-regulated environment. Collaborating across teams to improve and expand technology for orthopedic infections.

Posted 6/24/2026full-timeDallas • Texas • 🇺🇸 United StatesLead💰 $200,000 - $225,000 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

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

ATS Keywords

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Hard Skills & Tools

mechanical engineeringbiomedical engineeringelectrical engineeringsystems engineeringFDA-compliant design controlsverification and validation strategiesdesign architectureroot cause investigationsIEC 60601ISO 14971

Soft Skills

leadershipcommunicationorganizational skillsprioritization skillstechnical thinkingaccountabilityentrepreneurial spirithands-on engineering mindsetcollaborationmentoring

Certifications

Bachelor's degreeAdvanced degree (preferred)