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Process Engineer, R&D (Sr. or Principal level)
Osteal TherapeuticsUnited Statesfull_timeVerifiedPosted 8 May 2025
About the role
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, TXWork Schedule: Full-timePositions 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 (21 CFR 820) and ISO 13485, 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
Job Status: Full Time Exempt Reports To: Director of Research & Development Amount of Travel Required: Up to 30% Location: Dallas, TXWork Schedule: Full-timePositions 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 (21 CFR 820) and ISO 13485, 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
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