An emerging medical device company based in Austin, Texas is currently seeking a Mechanical Engineer to join our dynamic research and development team.
• You will support complex new product development efforts by executing engineering tasks including research, design, and validation as well as working with various other departments to engineer and bring new drug delivery systems into a production environment. This includes working with other engineering teams to ensure design for manufacturability and a high quality product.
• Products will include hand held mechanical unit dose drug delivery devices for ophthalmic, intranasal, oral, lyophilized applications and unit dose form fill seal (primary) drug-packaging systems.
• This person will play a crucial role in the development of a rapidly growing engineering operation, including primary responsibility for projects in the areas of engineering, design, process development, validation testing, and document control.
Responsibilities:
• Assist with the review of product development progress and evaluates results.
• Leadership responsibility on the research, development and qualification of materials, additives, and manufacturing methods for new and established products in all product categories.
• Define problems, collect data, establish facts, draw valid conclusions, conduct risk assessment then make recommendations and/or decisions based on the facts. Recommend necessary improvements and corrections to evaluation and qualification test specifications, technical analyses, and designs, to insure successful project completion.
• Review test reports for R&D projects to insure accuracy and correctness.
• Monitor and control assigned projects to assure compliance with approved procedures, methods, quality standards and regulations.
• Perform failure analysis and evolution of thermoplastics materials.
Experience/Qualification Requirements:
• Bachelor of Science in Mechanical Engineering, BSME.
• 5+ years experience in design, development (R&D), and validation of regulated medical devices with an emphasis in drug delivery a plus.
• Knowledge of the injection molding and thermoforming molding processes.
• Strong verbal, written, and presentation communications skills, ability to interface with clients and vendors, as well as experience with standard document control procedures.
• Familiarity with engineering laboratory equipment, test methodologies and standards.
• Experience with FDA quality systems in Class I, and Class II 510(k) medical devices, 21 CFR 820 (QSR), and design control is required.
• Project planning and project management experience with competency using Microsoft Project.
• The candidate will demonstrate a successful track record of hands-on involvement in delivery of technical project results in a fast-paced, creative environment with demanding schedules.
Software Requirements:
• Prior experience using SolidWorks and Cosmos (FEA) is required, a working knowledge of Computational Fluid Dynamics (CFD) modeling is desirable.
- Location: Austin, Texas
- Compensation: Competitive compensation commensurate with experience, health insurance, 401K and stock option plan.
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- Please, no phone calls about this job!
- Please do not contact job poster about other services, products or commercial interests.