Osteal Therapeutics
Process Engineer, R&D (Sr. or Principal level)
Osteal Therapeutics - Dallas
Work at Osteal Therapeutics
Overview
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Overview
Sr./Principal Process Engineer, R&D
Job Status: Full Time Exempt
Reports To: Director of Research & Development
Amount of Travel Required: Up to 30%
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 proactive Process Engineer to join our R&D organization and drive the development and optimization of prototype and production processes for our medical device portfolio. Reporting to the Director of R&D, you will lead DFM reviews, translate design concepts into scalable manufacturing methods, and design and commission custom test fixtures and assembly equipment. You will author and execute DV&V protocols in accordance with FDA QSR (21CFR820) and ISO13485, perform statistical analyses (DOE, capability studies, sample-size calculations), and manage design control documentation through the FDA waterfall/V-model lifecycle.
Essential Functions:
Essential functions of the position include but are not limited to the following. Other duties may be assigned.
• Lead cross-functional Design for Manufacturability (DFM) reviews with R&D, Quality, and Manufacturing to optimize product designs for cost, yield, and assembly efficiency.
• Work with contract manufacturers to develop, document, and qualify prototype and pilot production processes to support rapid iterations and ultimate product launch.
• Collaborate with design engineers to translate early designs into robust, scalable processes, providing feedback on tolerances, materials, and feature complexity.
• Design, build, and commission custom test fixtures, gages, and simple assembly equipment to enable repeatable verification and validation testing.
• Work with R&D designers to execute Design Verification & Validation (DV&V) protocols, including generation, test article fabrication, data collection, and report writing.
• Drive continuous improvement initiatives using appropriate methods (e.g., PFMEA).
• Manage design control documentation (Design History File, Device Master Record) in accordance with FDA QSR (21 CFR Part 820) and ISO 13485 requirements.
• Support supplier selection and qualification, including audit participation and supplier process validation
Position Qualifications:
Experience and Education
• Minimum B.S. degree in Engineering, Science, or related field.
• Minimum 5 or 8 years of experience (depending on level hired) in medical device or regulated-industry process development, preferably within implantable or combination products.
• Hands-on experience in prototype/manufacturing process development: machining, molding, assembly, or automation.
• Proven track record of successfully managing complex projects from initiation to completion.
• Self-starter with a strong bias for action; able to define and drive projects with minimal oversight.
• Strong organizational skills and attention to detail, with ability to manage multiple concurrent priorities and deliverables.
• Familiarity with the FDA waterfall/V-model design control lifecycle and associated gate reviews (User Needs, Design Input, Design Output, etc.).
• Experience calculating statistical sample sizes for verification studies and stability testing.
• Exposure to risk management per ISO 14971 and integration into process controls.
Skills and Abilities
• Proficient in statistical data analysis: hypothesis testing, capability analysis (Cp, Cpk), design of experiments (DOE), and sample-size determination.
• Solid grasp of Geometric Dimensioning & Tolerancing (GD&T) and its impact on manufacturability and inspection.
• Ability to author and review technical documents: protocols, procedures, work instructions, and validation reports.
• Strong project management skills: develop timelines, track milestones, manage resources, and escalate risks proactively.
• Aptitude for troubleshooting equipment and process anomalies; comfortable in a hands-on lab/manufacturing environment.
• Creative thinker, able to propose novel fixturing or automation solutions to challenging assembly or test requirements.
Computer Software / Programs
• Proficient in CAD software (e.g., SolidWorks).
• Proficient in MS Office, Smartsheet.
• Proficient in data analytics tools (e.g., Minitab).
The Process Engineer will play a key role in driving the success of our R&D projects, ensuring alignment with strategic objectives and delivering innovative medical device solutions. If you have the necessary skills and experience, we invite you to apply and contribute to making a difference in reducing mortality, morbidity, and the cost of care associated with musculoskeletal infections.
Job Status: Full Time Exempt
Reports To: Director of Research & Development
Amount of Travel Required: Up to 30%
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 proactive Process Engineer to join our R&D organization and drive the development and optimization of prototype and production processes for our medical device portfolio. Reporting to the Director of R&D, you will lead DFM reviews, translate design concepts into scalable manufacturing methods, and design and commission custom test fixtures and assembly equipment. You will author and execute DV&V protocols in accordance with FDA QSR (21CFR820) and ISO13485, perform statistical analyses (DOE, capability studies, sample-size calculations), and manage design control documentation through the FDA waterfall/V-model lifecycle.
Essential Functions:
Essential functions of the position include but are not limited to the following. Other duties may be assigned.
• Lead cross-functional Design for Manufacturability (DFM) reviews with R&D, Quality, and Manufacturing to optimize product designs for cost, yield, and assembly efficiency.
• Work with contract manufacturers to develop, document, and qualify prototype and pilot production processes to support rapid iterations and ultimate product launch.
• Collaborate with design engineers to translate early designs into robust, scalable processes, providing feedback on tolerances, materials, and feature complexity.
• Design, build, and commission custom test fixtures, gages, and simple assembly equipment to enable repeatable verification and validation testing.
• Work with R&D designers to execute Design Verification & Validation (DV&V) protocols, including generation, test article fabrication, data collection, and report writing.
• Drive continuous improvement initiatives using appropriate methods (e.g., PFMEA).
• Manage design control documentation (Design History File, Device Master Record) in accordance with FDA QSR (21 CFR Part 820) and ISO 13485 requirements.
• Support supplier selection and qualification, including audit participation and supplier process validation
Position Qualifications:
Experience and Education
• Minimum B.S. degree in Engineering, Science, or related field.
• Minimum 5 or 8 years of experience (depending on level hired) in medical device or regulated-industry process development, preferably within implantable or combination products.
• Hands-on experience in prototype/manufacturing process development: machining, molding, assembly, or automation.
• Proven track record of successfully managing complex projects from initiation to completion.
• Self-starter with a strong bias for action; able to define and drive projects with minimal oversight.
• Strong organizational skills and attention to detail, with ability to manage multiple concurrent priorities and deliverables.
• Familiarity with the FDA waterfall/V-model design control lifecycle and associated gate reviews (User Needs, Design Input, Design Output, etc.).
• Experience calculating statistical sample sizes for verification studies and stability testing.
• Exposure to risk management per ISO 14971 and integration into process controls.
Skills and Abilities
• Proficient in statistical data analysis: hypothesis testing, capability analysis (Cp, Cpk), design of experiments (DOE), and sample-size determination.
• Solid grasp of Geometric Dimensioning & Tolerancing (GD&T) and its impact on manufacturability and inspection.
• Ability to author and review technical documents: protocols, procedures, work instructions, and validation reports.
• Strong project management skills: develop timelines, track milestones, manage resources, and escalate risks proactively.
• Aptitude for troubleshooting equipment and process anomalies; comfortable in a hands-on lab/manufacturing environment.
• Creative thinker, able to propose novel fixturing or automation solutions to challenging assembly or test requirements.
Computer Software / Programs
• Proficient in CAD software (e.g., SolidWorks).
• Proficient in MS Office, Smartsheet.
• Proficient in data analytics tools (e.g., Minitab).
The Process Engineer will play a key role in driving the success of our R&D projects, ensuring alignment with strategic objectives and delivering innovative medical device solutions. If you have the necessary skills and experience, we invite you to apply and contribute to making a difference in reducing mortality, morbidity, and the cost of care associated with musculoskeletal infections.