Sr. Development Engineer, Orthopedic Hardware

Sr. Development Engineer, Orthopedic Hardware

Job Status: Full Time Exempt                                                 

Reports To: VP, R&D                                                              

Amount of Travel Required: up to 20%                             

Location: Dallas, TX

Work Schedule:  Hybrid – 3 days/week in-office 

Osteal Therapeutics, Inc. (Osteal) is a late clinical-stage biopharmaceutical company developing a novel pipeline of combination product therapeutics for musculoskeletal infections and their consequences. Our lead investigational candidate, VT-X7 was granted Breakthrough Therapy, Orphan Disease, FastTrack and Qualified Infectious Disease Product designations by the US Food and Drug Administration and is rapidly completing its clinical trial program for the treatment of Periprosthetic Joint Infection (PJI) with launch expected in 2025. A robust pipeline of additional indications and therapeutic candidates will lead to rapid and sustained growth for the foreseeable future. 

We are seeking an experienced Sr. Development Engineer to provide leadership support to our Orthopedic Hardware Products team within the R&D department. Reporting directly to the VP of R&D, the Senior Development Engineer will be responsible for the design, development, verification and validation of new and existing products for our orthopedic hardware portfolio. This role requires a strong technical background in mechanical engineering, desire to grow in leadership and the ability to collaborate effectively across teams. The Sr. Development Engineer will play a pivotal role in driving innovation, ensuring product quality, and meeting regulatory requirements in the orthopedic medical device sector.

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

·       Primary leader of assigned orthopedic hardware product development and sustaining projects.

·       Collaborate with cross-functional teams including R&D, Quality Assurance, Manufacturing, and Regulatory Affairs to achieve project goals and timelines.

·       Execute on the design, development, verification, and validation of new orthopedic hardware products, ensuring alignment with market needs and regulatory requirements.

·       Execute detailed mechanical component and assembly design CAD models.

·       Generate detailed product drawings, component specifications, and packaging documentation.

·       Manage design transfer activities from R&D to manufacturing, optimizing processes and ensuring scalability.

·       Manage and prioritize sustaining engineering efforts for existing orthopedic hardware products, addressing design improvements, component obsolescence, and manufacturing optimizations.

·       Implement corrective actions and continuous improvement initiatives based on post-market feedback and quality data.

·       Ensure compliance with FDA regulations (e.g., 21 CFR Part 820) and international standards (e.g., ISO 13485) for orthopedic medical devices.

·       Collaborate with Regulatory Affairs to support regulatory submissions and audits related to orthopedic hardware products.

·       Evaluate and recommend technologies, tools, and resources necessary for product development and sustaining activities.

Experience and Education

·       Minimum B.S. degree in Mechanical Engineering, Biomedical Engineering, or related field (M.S. or Ph.D. preferred).

·       Minimum 5 years of experience in engineering roles within the medical device industry.

·       Strong background in orthopedic hardware product development, including design, testing, and manufacturing processes.

·       Knowledge of materials selection, manufacturing processes (e.g., machining, casting), and product lifecycle management.

·       Experience in analytical processes (e.g., FEA, numerical modeling, Risk Analysis)

·       Experience with contract manufacturer development and working relationships

·       Experience with implantable orthopedic devices or surgical instrumentation.

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

·       Preferred 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.

·       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, or industry conferences (typically less than 15%).

Computer Software / Programs

·       Proficient in CAD software (e.g., SolidWorks).

·       Familiarity with statistical analysis systems (e.g.,  MATLAB, SAS) preferred.

·       Proficient in MS Office, Smartsheet

The Sr. Development Engineer, Orthopedic Hardware will contribute significantly to our efforts in sustaining and innovating our orthopedic hardware products, ensuring compliance with regulatory standards, and 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.

Please be advised that Osteal Therapeutics is not currently partnering with recruitment agencies for this position. We request that no unsolicited resumes or candidate profiles be submitted. All applications must be submitted directly through our company's career portal/website. Thank you for your understanding.