Senior/Principal Manufacturing Engineer

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. 

Job Status: Full Time Exempt                                                 

Reports To: Director, Manufacturing Engineering                                          

Amount of Travel Required: Up to 25%                                     

Location: Dallas, TX

Work Schedule: Full-time

Positions Supervised: None

POSITION SUMMARY

The Senior/Principal Manufacturing Engineer plans, designs and analyzes manufacturing processes for orthopedic devices and drug products.  Owns technical aspects of new-product-introduction activities to transfer designs robustly into manufacturing.  Determines equipment, tools, and processes needed to achieve manufacturing goals according to product specifications. Maximizes efficiency by optimization of layout of equipment, workflow, assembly methods, and work force utilization.

ESSENTIAL FUNCTIONS

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

Develop detailed layouts for equipment, manufacturing processes, and workflow.

Evaluate existing manufacturing processes to identify areas for improvements.

Research and develop new and/or improved processes, equipment, and products.

Design, purchase, install, characterize, and validate manufacturing equipment, fixtures, specialty assembly tools.

·       Develop, author, execute and document engineering investigations, process development studies, manufacturing work instructions, risk assessments, and validation protocols/reports (IQ, OQ, PQ).

·       Process owner for nonconformances and CAPAs that arise from manufacturing issues.

·       Own interactions with contract manufacturers and component suppliers for for issue resolution, component qualification, cost reduction and quality improvements.

Partner with Research to evaluate designs for manufacturability prior to production.

·       Preferred: Implement graphic arts designs and controlled content on finished product labels and packaging.

POSITION QUALIFICATIONS

Experience and Education

Experience:

·       Bachelor’s degree in engineering, preferably Mechanical Engineering, Electrical Engineering, Biomedical Engineering or related field required. 

·       Minimum 5 years’ experience in medical devices, including a minimum of 3 years supporting active manufacturing operations under strict quality-system controls.

·       Experience in manufacturing orthopedic devices is highly preferred.

·       Experience in contract manufacturing required.

·       Experience with manual and semi-automated assembly processes for electromechanical devices required.

·       Familiar with processes for sterilization, bioburden, and endotoxin testing.

·       Experienced with design transfer / new product introduction; has borne significant responsibilities in successful launch of at least one product, ideally orthopedic.

·       Experienced in requirements development, design-change analysis, risk management, and change-control procedures.

·       Understanding of GxP, FDA Quality System Regulations, ISO 13485, and ISO 14971.

Skills and Abilities

Excellent organizational and communication skills.

·       Ability to prioritize tasks and manage multiple projects effectively.

·       Demonstrates entrepreneurial spirit; able to thrive and contribute impactfully in an agile startup environment.

·       Hands-on, driven work ethic, with high attention to detail, and high ownership approach to process/product quality.

·       Ability to communicate complex technical data in format appropriate to support critical decision-making activities; excellent presentation skills and technical writing ability.

·       Solid grasp of statistical methods applicable to process development, investigations, and validation.

·       Able to engage effectively with peers and project colleagues at contract manufacturing organizations, and with suppliers.

Computer Software / Programs

Required proficiencies:

·       Microsoft Office

·       Google Suite

·       SolidWorks or comparable CAD software

·       Minitab or comparable statistics software

Desired proficiencies:

·       SmartSheet project management software

·       Python programming language

·       Graphic-art software (e.g., Adobe Illustrator)

·       Commercial label-generation software (e.g., Bartender, Nicelabel, Labelview)

COMPENSATION AND BENEFITS

Osteal Therapeutics offers a competitive compensation and benefits package, including salary, bonus potential, equity ownership, health insurance, dental insurance, vision insurance, paid time off, and a 401(k) plan.

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.