Development Engineer, NPD (Sr. or Principal level)

Osteal Therapeutics; Dallas (TX); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is on the lookout for a talented Development Engineer to join their innovative R&D team. This role is pivotal in designing and developing cutting-edge drug delivery devices aimed at addressing orthopedic infections. You will collaborate with various teams, ensuring that products meet user needs and regulatory standards while leading projects from concept to commercialization. If you are driven by the desire to make a significant impact in the medical field, this opportunity offers a chance to contribute to groundbreaking advancements in patient care and product development.

Qualifications

• Minimum 5 years in medical device/life science product development.
• Proficient in CAD software and analytical tools.
• Experience with FDA requirements and Good Design Practices.

Responsibilities

• Lead new product development projects ensuring quality deliverables.
• Develop and review mechanical designs and product specifications.
• Collaborate with cross-functional teams for product commercialization.

Skills

Mechanical Engineering

Biomedical Engineering

Product Development

User Needs Analysis

CAD Software (SolidWorks)

Analytical Skills

Risk Analysis

Human Factors Engineering

Communication Skills

Organizational Skills

Education

Bachelor's Degree in Mechanical Engineering

Master's Degree in Biomedical Engineering

Tools

SolidWorks

MS Office

Smartsheet

Minitab

Job description

Sr./Principal Development Engineer, NPD

Job Status: Full Time Exempt

Reports To: Director of Research & Development

Amount of Travel Required: Up to 15%

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 talented and driven Development Engineer, New Product Development, to join our dynamic R&D team. This individual will play a crucial role in the design, development, verification, and validation of new drug delivery devices. Reporting directly to the Director of R&D, the Development Engineer, NPD, will work closely with cross-functional teams, including Applied Research, Marketing, Regulatory Affairs/Quality Assurance (RA/QA), and contract manufacturers, to bring innovative products from concept to commercialization.

Essential Functions:

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

· Lead and contribute to new product development projects, ensuring timely and high-quality deliverables.

· Capture User Needs, Product Requirements, and Design Inputs/Outputs to execute product Verification and Validation testing.

· Develop and review detailed mechanical component and assembly designs using CAD models.

· Generate detailed product drawings, component specifications, and packaging documentation.

· Review the work and support the development of junior engineers. (This role is a player/coach)

· Create and maintain FDA and ISO compliant design history files and design master records.

· Collaborate with Applied Research to provide design input for future product development.

· Support the design of tooling and fixtures to optimize manufacturing processes.

· Support the development of manufacturing assembly processes and procedures.

· Work with contract manufacturers to establish and drive new product introductions and design transfers.

· Ensure compliance with Good Design Practices (GDP) and company standards.

· Assist Regulatory Affairs with manufacturing materials and process flow documents.

· Support Quality in complaint handling and regulatory compliance.

Position Qualifications:

Experience and Education

· Minimum B.S. degree in mechanical, biomedical, or related engineering field. (M.S. preferred)

· Minimum 5 or 8 years of experience (depending on level) in medical device/life science product development.

· Proficient in CAD software (e.g., SolidWorks).

· Experience with the design of machined and injection-molded components.

· Strong analytical skills, including experience with FEA, numerical modeling, and risk analysis.

· Hands-on technical skills for prototyping and testing.

· Experience with Human Factors Engineering and user studies.

· Effective communication and organizational skills.

· Ability to work independently and within project teams.

· Experience with sterile disposable devices.

· Knowledge of FDA requirements for Good Laboratory Practices (GLP).

· Understanding of FDA GDP regulations and ISO 13485.

Skills and Abilities

· Excellent organizational and communication skills.

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

· Willing and able to travel as needed (typically 10-15%).

Computer Software / Programs

· Proficient in CAD software (e.g., SolidWorks).

· Proficient in MS Office, Smartsheet.

· Proficient in data analytics tools (e.g., Minitab).

This position will play a critical role in advancing our innovative drug delivery devices, contributing to the overall success and growth of our company. If you are passionate about making a difference in reducing mortality, morbidity, and the cost of care associated with musculoskeletal infections and possess the required qualifications, we encourage you to apply.