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Associate Development Engineer,
Sustaining & NPI Support

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Job Status: 3-month contract-to-hire 

Reports to: Senior Development Engineer

Amount of Travel Required: Up to 15%

Location: Dallas, TX - Hybrid

Work Schedule:  Full-time

Positions Supervised: None

 

Osteal Therapeutics:

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. 

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Position Summary:

We are seeking an Associate Product Development Engineer to join our Drug Delivery System team within the R&D department. The Associate Product Development Engineer will be responsible for supporting sustaining and new product development initiatives as part of a cross-functional development team.

 

Essential Functions:

Essential functions of the position include but are not limited to the following:​

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  • Testing: Support the planning and execution of product verification and validation, including preparing technical memos, protocols and reports.

  • Problem-Solving: Brainstorm solutions, design experiments and implement improvements with some guidance.

  • Documentation: Prepare, track and process R&D documentation change requests related to engineering drawings, specifications, artwork, and other supporting documentation with supervision.

  • Compliance: Ensure adheres to regulatory and industry standards and guidelines for medical device development, including FDA GDP, ISO 13485, and internal quality procedures.

  • Collaboration: Work with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing.

  • Other duties may be assigned.

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Position Qualifications:

Experience and Education:

  • Minimum B.S. degree in Biomedical Engineering, Mechanical Engineering, or related field.

  • Minimum of 1 year of medical device product design and development experience required.

  • Solid understanding of engineering principles and practices.

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Skills and Abilities:

  • Ability to prioritize and manage multiple tasks effectively.

  • Ability to communicate technical or project progress related results and issues, both verbally and in written form.

  • Hands-on, driven work ethic and entrepreneurial spirit.

  • Willing and able to travel for project-related testing (typically less than 15%).

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Computer Software / Programs:

  • Experience with CAD software (e.g., SolidWorks) and engineering analysis tools.

  • Proficient in MS Windows and MS Office Applications (e.g., Word, Excel, PowerPoint).

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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.

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