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The main purpose of this job is to support development of current and next generation drug-coated balloon (DCB) projects to treat peripheral vascular disease. These combination products integrate biotechnology, polymer science, and pharmaceutical molecules onto balloon platforms. The employee will be a member of multiple projects through different stages of the product development cycle, bringing products to commercialization.
• Assist in the development of new combination products and components.
• Support the development and integration of new technologies into the CardioVascular product offering.
• Provide assistance to interdepartmental team for new product introduction.
• Take an active role in early stage design control activities leading to a first in man study (innovation, proof of principle, product development, process development, and equipment development) such that a robust pilot line that is scaleable and transferable to commercial manufacturing is achievable.
• Document research and development process through lab notebooks, engineering characterization studies, and test reports.
• Work with Regulatory Affairs (RA) to compile US and OUS regulatory submissions. Assist RA with answering subsequent questions from regulatory bodies.
• Design and develop new test methods and equipment specific to new products. Train technicians in new processes.
• Create document change orders (CO's) for design, materials, and process documentation.
• Work with Regulatory, Preclinical, Quality, and Manufacturing departments to create product performance, design, and manufacturing specifications.
• Perform competitive product analyses.
• Work with patent counsel to file and evaluate intellectual property.
• Interact frequently with all departments within organization and occasionally with external physicians, consultants, and vendors.
• Minimum travel requirement of 10%.
IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME
Bachelor's Degree in Engineering (Chemical, Materials, Mechanical or Biomedical) or Chemistry
Years of Experience
Specialized Knowledge or Skills Required
• Experience in R&D, Quality and/or Manufacturing in a regulated industry, working through different phases of product development.
• Complete understanding and wide application of technical principles, theories, and concepts toward product, process, and technology development and evaluation.
• Able to provide imaginative, thorough and practical technical solutions to a wide range of difficult problems, consistent with company's objectives.
• Successful collaboration as part of a cross-functional team.
• Background demonstrating strong self-motivation; able to works under only general direction, independently determining and developing approaches to solutions.
• Proficient with computer applications (i.e. Word, Excel, PowerPoint, Minitab, etc.).
• Ability to communicate well (both written and verbal).
• Master's degree.
• 2+ years working in R&D, Quality and/r Manufacturing on combination medical devices.
• Experience with test method validation.
• Knowledge of design of experiments (DOE) and statistical techniques.
• Proficient with SolidWorks.
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About LanceSoft Inc
Lancesoft is one of fastest growing and largest clinical staffing firm in the U.S. and an employer-of-choice for over 1000+ consultants - this may be your opportunity to join us!
We recruit top-notch talent for Healthcare, Pharmaceutical, Technology, Telecom, Retail and Distribution, Energy & Utilities, Banking/ Finance, Manufacturing, Automobile, Media, Transportation, and Government clients coast-to-coast across the US, Canada and India. We are one of the fastest-growing companies in the industry and
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