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Engineering Program Lead, NPD
Job Status: Full Time Exempt
Reports To: Director of Research & Development
Amount of Travel Required: Up to 15%
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 strategic and technically adept Engineering Program Lead, New Product Development (NPD) to join our high-performing R&D team. This individual will be responsible for leading the end-to-end engineering execution and cross-functional coordination of next-generation drug delivery devices. Reporting to the Director of R&D, the Engineering Program Lead, NPD, will serve as the technical and program point person driving product design, development, and verification activities while ensuring alignment across teams including Applied Research, Marketing, RA/QA, Manufacturing, and external partners. This role is ideal for a systems-minded engineering leader who thrives on innovation, collaboration, and delivering transformative technologies from concept to commercialization.
Essential Functions:
Essential functions of the position include but are not limited to the following. Other duties may be assigned.
· Overall program delivery for new product development projects, ensuring timely and high-quality deliverables.
· Lead planning and road mapping across several technical programs across multiple teams.
· Capture User Needs, Product Requirements, and Design Inputs/Outputs to execute product Verification and Validation testing.
· Develop and review detailed mechanical component and assembly designs using CAD models.
· Generate detailed product drawings, component specifications, and packaging documentation.
· Review the work and support the development of junior engineers. (This role is a player/coach)
· Create and maintain FDA and ISO compliant design history files and design master records.
· Collaborate with Applied Research to provide design input for future product development.
· Support the design of tooling and fixtures to optimize manufacturing processes.
· Support the development of manufacturing assembly processes and procedures.
· Work with contract manufacturers to establish and drive new product introductions and design transfers.
· Ensure compliance with Good Design Practices (GDP) and company standards.
· Assist Regulatory Affairs with manufacturing materials and process flow documents.
· Support Quality in complaint handling and regulatory compliance.
Position Qualifications:
Experience and Education
· Minimum B.S. degree in mechanical, biomedical, or related engineering field. (M.S. preferred)
· Minimum 9-12 years of experience in medical device/life science product development.
· Proficient in CAD software (e.g., SolidWorks).
· Experience with the design of machined and injection-molded components.
· Strong analytical skills, including experience with FEA, numerical modeling, and risk analysis.
· Hands-on technical skills for prototyping and testing.
· Experience with Human Factors Engineering and user studies.
· Effective communication and organizational skills.
· Ability to work independently and within project teams.
· Experience with sterile disposable devices.
· Knowledge of FDA requirements for Good Laboratory Practices (GLP).
· Understanding of FDA GDP regulations and ISO 13485.
Skills and Abilities
· Excellent organizational and communication skills.
· Hands-on, driven work ethic and entrepreneurial spirit.
· Willing and able to travel as needed (typically 10-15%).
Computer Software / Programs
· Proficient in CAD software (e.g., SolidWorks).
· Proficient in MS Office, Smartsheet.
· Proficient in data analytics tools (e.g., Minitab).
This position will play a critical role in advancing our innovative drug delivery devices, contributing to the overall success and growth of our company. If you are passionate about making a difference in reducing mortality, morbidity, and the cost of care associated with musculoskeletal infections and possess the required qualifications, we encourage you to apply.
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