Please note this is a 7 month contract position. Provide technical support in the development and commercialization of new drug products and modifications to marketed products in a global environment. Responsibilities include engineering design and development work, prototype feasibility testing, and other development activities necessary to commercial drug delivery systems in a pharmaceutical environment. All work will be completed in compliance with design control regulations as established by the regulatory bodies. Specific details include: •Perform complex, hands-on simulated testing for design verification and test method development •Review and edit all engineering documentation related to assigned projects. This includes technical protocols, reports, and design control documentation. •Translate complex design concepts and ideas into working drawings and specifications. •Review specifications, drawings, etc. to improve designs and to resolve design problems. •Apply advanced engineering methodologies to product development activities •Maintain ownership of device specifications and participate in drafting pertinent sections of Regulatory Filings. •Help to manage, maintain, and improve the device development lab. •Up to 25% travel required. Qualifications Bachelors Degree in Mechanical or Biomedical Engineering, or equivalent with 4-6 years experience in device development engineering in a pharmaceutical, medical device, or related field. Experience in the design, development, and commercialization of Class II medical devices. Working knowledge and experience applicable regulations and with ISO and ASTM standards is preferred. Must be effective communicator in team environment with strong interpersonal skills and have the ability to interface effectively with research, operations, and external suppliers and manufacturers. Primary Location: Spring House, PA For consideration please include Dice # 1047.
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