Job responsibilities include but are not limited to the following and are subject to change:The ideal candidate will need to demonstrate good knowledge of engineering and industry standards, as well as good writing and communication skills.Design and develop medical devices including, but not limited to catheter products, molded plastic handles, catheter balloon design, and multi-lumen channel designDefine product requirements and component specificationsDesign and development of toolingPerform experiments to determine validity of designsDesign verification, process qualifications, equipment installations, and product and process validations.Identify processes to fabricate new products and test/manufacturing jigs.Review existing patents to determine infringement status as well as generate new IP during the course of development projects.Develop and perform tests to verify product integrity in the design phaseGather input from clinical, marketing, literature and other internal and external sourcesPrepare product documentation including DHF, drawings, BOM, test protocols and reports, DCOs, etc.Comply with applicable FDA and international regulatory laws/standardsAssist in the transfer of newly developed products from R&D to productionOther duties as assigned or requiredPreferred applicant requirements:Individual must have solid technical and mechanical ability, skills, process knowledgeExperience with medical device R&D from concept to commercialization preferredCAD experience in SolidWorks is preferred.Thorough understanding of FDA and ISO 13485 Quality Systems Regulations.Strong written and oral communication and interpersonal skills are a must.Ability to work independently and to manage multiple tasks and projects in a fast-paced, changing environment is essential.Note: This position is being offered initially as an internship for new graduates, or students graduating this year. The intent is to find new employees for a permanent position at the conclusion of the internship. The internship allows for the required training and for the new employee to adjust to working at Biotex.