top of page

Packaging Engineer

​

Job Title: Packaging Engineer

Job Status: Full Time Exempt

Reports to: VP, R&D

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 dedicated Packaging Engineer to join our Orthopedic Hardware Products team within the R&D department. Reporting to the Engineering Manager, the Packaging Engineer will be responsible for designing and implementing commercial packaging solutions for our orthopedic hardware products. This role requires a strong background in packaging engineering, attention to detail, and the ability to manage projects effectively from concept to commercialization. The Packaging Engineer will collaborate closely with cross-functional teams, including Operations, to ensure packaging designs meet regulatory requirements, enhance product protection, and optimize supply chain efficiency.

 

Essential Functions:

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

​​

  • Develop packaging concepts and designs that meet product specifications, regulatory requirements, and commercialization goals.

  • Create detailed packaging specifications, drawings, and documentation for manufacturing and assembly.

  • Manage packaging validation activities, including testing for product compatibility, shelf life, and transportation hazards.

  • Collaborate with contract manufacturers and suppliers to ensure packaging materials and processes meet quality and cost requirements.

  • Ensure packaging designs comply with FDA regulations (e.g., 21 CFR Part 820) and international standards (e.g., ISO 11607).

  • Support Regulatory Affairs in preparing packaging documentation for regulatory submissions and audits.

  • Plan and execute packaging development projects, adhering to timelines, budgets, and quality standards.

  • Communicate effectively with stakeholders to provide updates on project progress and resolve issues as they arise.

  • Identify opportunities for cost savings, process improvements, and sustainability initiatives related to packaging design and materials.

​​

Position Qualifications:

Experience and Education

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

  • Minimum 5-7 years of experience in packaging engineering roles within the medical device or pharmaceutical industry.

  • Knowledge of packaging materials, sterilization methods, and manufacturing processes.

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

  • Experience with sterile medical device packaging and regulatory requirements (e.g., ISO 11607).

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

  • Knowledge of FDA requirements for Good Laboratory Practices (GLP).

  • Understanding of FDA GDP regulations and ISO 13485.

 

Skills and Abilities

  • 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, MS Project

​

The Packaging Engineer 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.

​

bottom of page