Sr./Principal Development Engineer, 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 talented and driven Development Engineer, New Product Development, to join our dynamic R&D team. This individual will play a crucial role in the design, development, verification, and validation of new drug delivery devices. Reporting directly to the Director of R&D, the Development Engineer, NPD, will work closely with cross-functional teams, including Applied Research, Marketing, Regulatory Affairs/Quality Assurance (RA/QA), and contract manufacturers, to bring innovative products from concept to commercialization.
Essential Functions:
Essential functions of the position include but are not limited to the following. Other duties may be assigned.
· Lead and contribute to new product development projects, ensuring timely and high-quality deliverables.
· 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 5 or 8 years of experience (depending on level) 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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