Osteal Therapeutics
Director/Senior Director of Manufacturing Engineer
Osteal Therapeutics, Dallas, Texas, United States, 75215
Position Summary
The Director of Manufacturing Engineering is a key leadership role responsible for establishing, managing, and advancing the manufacturing engineering function at Osteal Therapeutics. This individual will lead the scale‑up and commercialization of the company’s Class II medical devices, driving the successful transition from clinical builds to full-volume production. In close collaboration with R&D, this role owns manufacturing process development, design transfer, and process validation activities to ensure robust, compliant, and scalable operations.
Acting as a strategic and technical leader, the Director partners closely with Production, R&D, Quality/Regulatory, and Supply Chain teams to execute product and operational initiatives with excellence. Reporting directly to the COO, this position plays a critical role in shaping the company’s manufacturing strategy, building high‑performing teams, and ensuring readiness for commercial growth under FDA and ISO quality system requirements.
Essential Functions Essential functions of the position include but are not limited to the following. Other duties may be assigned.
Define and drive the long‑term manufacturing engineering strategy, ensuring alignment with company growth objectives and operational goals.
Lead the design, validation, and continuous optimization of manufacturing processes to enhance efficiency, cost‑effectiveness, and product quality.
Champion Design for Manufacturability (DFM) principles throughout product development to ensure smooth transition into scalable production.
Serve as a key cross‑functional interface between R&D, Quality, Supply Chain, and external partners to ensure seamless execution from concept to commercialization.
Build, mentor, and manage a high‑performing manufacturing engineering team capable of supporting both development and commercial operations.
Act as primary operational leader for all commercial contract manufacturing activities, including performance management and continuous improvement with CMOs.
Lead manufacturing readiness and execution for product builds from clinical manufacturing through launch and commercial scale‑up.
Oversee supply chain engineering functions, including production equipment, calibration, tooling, and fixture management.
Drive cost‑of‑goods (COGS) reduction initiatives, reliability improvements, and ongoing DFM enhancements to support margin goals.
Lead process improvements, process validations, and the development and maintenance of test methodologies.
Own the creation, control, and continuous improvement of technical documentation, including BOMs, manufacturing process instructions (MPIs), and inspection procedures via formal change control.
Design and implement production tooling to optimize throughput and ensure repeatable manufacturing outcomes.
Provide manufacturing engineering input to R&D teams to influence design decisions and future product architecture.
Partner with Regulatory Affairs to develop compliant manufacturing process documentation, material specifications, and process flow descriptions for submissions.
Contribute to the development and maintenance of FDA and ISO‑compliant design & development and risk management files.
Ensure ongoing compliance with Good Manufacturing Practices (GMP) and support internal and external audit readiness.
Position Qualifications Experience and Education Education: Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or related field) required; advanced degree preferred.
Industry Tenure: Minimum of 10 years of progressive experience in medical device manufacturing, including at least 5 years in a leadership or key support role within active manufacturing operations under a regulated quality system.
Orthopedic Expertise: Direct experience with orthopedic implant manufacturing is highly preferred.
Electromechanical Assembly: Background in manual and semi‑automated assembly processes for electromechanical medical devices preferred.
Contract Manufacturing: Proven experience collaborating with and managing contract manufacturing organizations (CMOs) is required.
Sterile Devices: Experience with sterile, single‑use disposable medical devices is strongly preferred.
NPI & Design Transfer: Demonstrated success in leading new product introduction (NPI) and design transfer activities, including transitioning products to contract manufacturing partners.
Product Launch Leadership: Has held significant responsibility in the successful commercial launch of at least one medical device product, ideally within orthopedics.
Technical Documentation & Controls: Skilled in requirements development, design change analysis, risk management, and execution of change control procedures.
Regulatory & Quality Systems: Strong working knowledge of GxP principles, FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and ISO 14971.
Skills and Abilities
Proven ability to build, develop, and lead high‑performing engineering and operations teams.
Exceptional organizational discipline and communication skills, with the ability to align cross‑functional stakeholders.
Strong prioritization and multitasking capabilities, with demonstrated success managing multiple concurrent projects in a fast‑paced environment.
Entrepreneurial mindset with the agility, initiative, and resourcefulness needed to excel in a startup culture.
Hands‑on, driven approach with a high degree of ownership, attention to detail, and commitment to product and process quality.
Ability to translate complex technical information into clear, actionable insights tailored for technical and executive decision‑making; strong presentation and technical writing skills.
Proficient in applying statistical tools and methodologies for process development, root cause investigations, and validation activities.
Skilled at building productive working relationships with contract manufacturing partners, suppliers, and cross‑functional internal teams.
Computer Software / Programs Required Proficiencies
Microsoft Office
Google Suite
SolidWorks or comparable CAD software
Minitab or comparable statistics software
Desired Proficiencies
SmartSheet project 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.
Equal‑Opportunity Employer We are an equal‑opportunity employer and value diversity at our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Osteal Therapeutics, Inc. 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 U.S. 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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Acting as a strategic and technical leader, the Director partners closely with Production, R&D, Quality/Regulatory, and Supply Chain teams to execute product and operational initiatives with excellence. Reporting directly to the COO, this position plays a critical role in shaping the company’s manufacturing strategy, building high‑performing teams, and ensuring readiness for commercial growth under FDA and ISO quality system requirements.
Essential Functions Essential functions of the position include but are not limited to the following. Other duties may be assigned.
Define and drive the long‑term manufacturing engineering strategy, ensuring alignment with company growth objectives and operational goals.
Lead the design, validation, and continuous optimization of manufacturing processes to enhance efficiency, cost‑effectiveness, and product quality.
Champion Design for Manufacturability (DFM) principles throughout product development to ensure smooth transition into scalable production.
Serve as a key cross‑functional interface between R&D, Quality, Supply Chain, and external partners to ensure seamless execution from concept to commercialization.
Build, mentor, and manage a high‑performing manufacturing engineering team capable of supporting both development and commercial operations.
Act as primary operational leader for all commercial contract manufacturing activities, including performance management and continuous improvement with CMOs.
Lead manufacturing readiness and execution for product builds from clinical manufacturing through launch and commercial scale‑up.
Oversee supply chain engineering functions, including production equipment, calibration, tooling, and fixture management.
Drive cost‑of‑goods (COGS) reduction initiatives, reliability improvements, and ongoing DFM enhancements to support margin goals.
Lead process improvements, process validations, and the development and maintenance of test methodologies.
Own the creation, control, and continuous improvement of technical documentation, including BOMs, manufacturing process instructions (MPIs), and inspection procedures via formal change control.
Design and implement production tooling to optimize throughput and ensure repeatable manufacturing outcomes.
Provide manufacturing engineering input to R&D teams to influence design decisions and future product architecture.
Partner with Regulatory Affairs to develop compliant manufacturing process documentation, material specifications, and process flow descriptions for submissions.
Contribute to the development and maintenance of FDA and ISO‑compliant design & development and risk management files.
Ensure ongoing compliance with Good Manufacturing Practices (GMP) and support internal and external audit readiness.
Position Qualifications Experience and Education Education: Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or related field) required; advanced degree preferred.
Industry Tenure: Minimum of 10 years of progressive experience in medical device manufacturing, including at least 5 years in a leadership or key support role within active manufacturing operations under a regulated quality system.
Orthopedic Expertise: Direct experience with orthopedic implant manufacturing is highly preferred.
Electromechanical Assembly: Background in manual and semi‑automated assembly processes for electromechanical medical devices preferred.
Contract Manufacturing: Proven experience collaborating with and managing contract manufacturing organizations (CMOs) is required.
Sterile Devices: Experience with sterile, single‑use disposable medical devices is strongly preferred.
NPI & Design Transfer: Demonstrated success in leading new product introduction (NPI) and design transfer activities, including transitioning products to contract manufacturing partners.
Product Launch Leadership: Has held significant responsibility in the successful commercial launch of at least one medical device product, ideally within orthopedics.
Technical Documentation & Controls: Skilled in requirements development, design change analysis, risk management, and execution of change control procedures.
Regulatory & Quality Systems: Strong working knowledge of GxP principles, FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and ISO 14971.
Skills and Abilities
Proven ability to build, develop, and lead high‑performing engineering and operations teams.
Exceptional organizational discipline and communication skills, with the ability to align cross‑functional stakeholders.
Strong prioritization and multitasking capabilities, with demonstrated success managing multiple concurrent projects in a fast‑paced environment.
Entrepreneurial mindset with the agility, initiative, and resourcefulness needed to excel in a startup culture.
Hands‑on, driven approach with a high degree of ownership, attention to detail, and commitment to product and process quality.
Ability to translate complex technical information into clear, actionable insights tailored for technical and executive decision‑making; strong presentation and technical writing skills.
Proficient in applying statistical tools and methodologies for process development, root cause investigations, and validation activities.
Skilled at building productive working relationships with contract manufacturing partners, suppliers, and cross‑functional internal teams.
Computer Software / Programs Required Proficiencies
Microsoft Office
Google Suite
SolidWorks or comparable CAD software
Minitab or comparable statistics software
Desired Proficiencies
SmartSheet project 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.
Equal‑Opportunity Employer We are an equal‑opportunity employer and value diversity at our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Osteal Therapeutics, Inc. 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 U.S. 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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