Technical Project Manager

Technical Project Manager, R&D

Job Status: Full Time Exempt                                                 

Reports To: R&D                                                            

Amount of Travel Required: None                                       

Location: Dallas, TX

Work Schedule: Full-time

Positions Supervised: None

Osteal Therapeutics:

Osteal Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a novel pipeline of combination therapies for orthopedic infections and their consequences. Our lead investigational candidate, VT-X7 was granted Orphan Drug, FastTrack and Qualified Infectious Disease Product designations by the FDA and is currently in late-stage clinical trials for the treatment of Periprosthetic Joint Infection (PJI). With a robust pipeline of additional indications and therapeutic candidates, we anticipate rapid and sustained growth.

Position Summary:

We are seeking a skilled Technical Project Manager with specific experience in the medical device industry to lead and manage projects within our R&D team. This individual will play a crucial role in overseeing project execution, from initiation through completion, ensuring alignment with strategic goals, timelines, and regulatory requirements. Reporting to the VP of R&D, the Technical Project Manager will collaborate closely with cross-functional teams, stakeholders, and external partners to deliver high-quality medical device products. This role requires strong project management skills, technical expertise, and a proactive approach to problem-solving and decision-making.

Essential Functions:

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

· Lead project planning activities, including defining scope, milestones, resource requirements, and timelines.

· Establish project schedules, track progress, and manage project risks and issues effectively.

· Collaborate with R&D, Engineering, Quality Assurance, Regulatory Affairs, and Manufacturing teams to ensure project objectives are met.

· Facilitate communication and alignment between stakeholders throughout the project lifecycle.

· Allocate resources, including personnel, equipment, and budget, to support project activities and deliverables.

· Monitor resource utilization and adjust plans as needed to optimize project outcomes.

· Identify project risks and develop mitigation strategies to minimize impact on project timelines and deliverables.

· Ensure projects adhere to regulatory requirements (e.g., FDA regulations, ISO standards) and company quality management systems.

· Maintain accurate project documentation, including project plans, schedules, status reports, and meeting minutes.

· Prepare and present project updates to senior management, stakeholders, and project teams.

· Drive process improvements and best practices in project management methodologies within the R&D team.

· Foster a culture of innovation, collaboration, and accountability among project team members.

Position Qualifications:

Experience and Education

· Minimum B.S. degree in Engineering, Science, or related field (M.S. or MBA preferred).

· Minimum 5-7 years of experience as a Technical Project Manager, preferably in the medical device industry.

· Proven track record of successfully managing complex projects from initiation to completion.

· Knowledge of project management tools and methodologies (e.g., Agile, Waterfall).

· Familiarity with medical device development processes, including design control and risk management.

· Understanding of FDA GDP regulations and ISO 13485.

Skills and Abilities

· Excellent leadership, communication, and interpersonal skills.

· Strong problem-solving and decision-making abilities.

· Ability to influence and motivate cross-functional teams without direct authority.

· Detail-oriented with a focus on delivering high-quality project outcomes.

· Ability to prioritize tasks and manage multiple projects effectively

· Hands-on, driven work ethic and entrepreneurial spirit

Computer Software / Programs

· Smartsheet

The Technical Project Manager will play a key role in driving the success of our R&D projects, ensuring alignment with strategic objectives and delivering innovative medical device solutions. If you have the necessary skills and experience, we invite you to apply and contribute to making a difference in reducing mortality, morbidity, and the cost of care associated with musculoskeletal infections.