R&D Engineer, Medical Devices & Packaging Support - Osteal Therapeutics

Job Status: Full Time Exempt

Reports To: Sr Engineering Manager

Amount of Travel Required: up to 15%

Location: Dallas, TX

Work Schedule: Full-time

Positions Supervised: None

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.

We are seeking a highly motivated R&D Engineer, Medical Devices & Packaging Support to join our dynamic team. The ideal candidate will play a key role in the research, development, and optimization of medical devices, related systems, and packaging. This position offers a broad scope of responsibilities, including the development of device components, system integration, and packaging solutions. The successful candidate will work across multiple functional areas, supporting cross-disciplinary projects to ensure that medical devices meet performance, safety, supply chain efficiency, and regulatory standards.

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

Product Development: Participate in the end-to-end development of medical devices, contributing to the design, testing, and optimization of various components, including packaging, ensuring functionality, safety, and reliability.

Cross-functional Collaboration: Work closely with design, manufacturing, regulatory, and quality assurance teams to integrate all components (hardware, software, packaging) into a cohesive system.

Packaging Support: Contribute to the development and testing of packaging solutions that ensure the safe transport, storage, and functionality of the medical device, while meeting regulatory standards and sustainability goals.

Prototyping and Testing: Assist in the creation of prototypes for new medical devices and packaging components. Conduct tests and analyze data to support continuous improvement of the products.

Regulatory Compliance: Ensure that all components, including packaging, adhere to industry regulations (FDA, ISO, etc.) and that they meet medical device quality and safety standards.

Documentation: Maintain detailed records of development processes, test results, and regulatory documentation to ensure compliance and traceability.

Problem Solving: Identify and troubleshoot technical challenges during the development process, ensuring timely resolution to keep projects on track.

Continuous Improvement: Support initiatives aimed at improving product performance, reducing costs, and enhancing the overall quality and sustainability of medical devices and packaging solutions.

Research: Stay up to date with advancements in medical device technologies, materials, and packaging innovations, contributing insights and ideas to drive innovation.

Experience and Education

Minimum B.S. degree in Biomedical Engineering, Packaging Engineering, Mechanical Engineering, Material Science or related field (M.S. preferred).

Minimum 3-5 years of experience in medical device development with at least 1 year experience supporting packaging development on projects within the medical device or pharmaceutical industry.

Knowledge of medical device development processes, design controls, packaging materials, sterilization methods, and regulatory requirements. Familiarity with CAD, prototyping, and testing methodologies.

Familiarity with ASTM and ISTA standards for packaging testing and validation.

Familiarity with design for manufacturability (DFM) and design for assembly (DFA) principles.

Familiarity with medical device regulatory standards (FDA, ISO 13485, CE marking).

Proficiency in product lifecycle management (PLM) tools and systems.

Skills and Abilities

Strong analytical and technical skills, with the ability to troubleshoot and resolve complex issues.

Excellent collaboration and communication skills, with the ability to work effectively in a cross-functional team environment.

Strong organizational skills with an emphasis on documentation and regulatory compliance.

Ability to prioritize tasks and manage multiple projects effectively

Hands-on, driven work ethic and entrepreneurial spirit

Willing and able to travel for project-related meetings, supplier visits (typically less than 15%).

Computer Software / Programs

Proficient in packaging design software (e.g., ArtiosCAD, SolidWorks).

Proficient in MS Office, Smartsheet

The R&D Engineer, Medical Devices & Packaging Support will contribute significantly to our efforts in optimizing packaging solutions for efficient commercialization. If you have the required skills and qualifications, we invite you to apply and join our team dedicated to making a difference in reducing mortality, morbidity, and the cost of care associated with musculoskeletal infections.

Osteal Therapeutics, Inc. is an equal opportunity employer. We are committed to creating a diverse environment and are proud to be an affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

We encourage individuals of all backgrounds to apply and welcome the opportunity to work with talented individuals who contribute to our success.