Project Engineer: Gastroenterology and CT Colonogr
Location: Melville New York
Description: The Judge Group is hiring Project Engineer: Gastroenterology and CT Colonogr right now, this job will be placed in New York. Detailed specification about this job opportunity kindly read the description below. Leading diagnostic client seeks a P roject Engineer: Gastroenterology and CT Colonography for a contract to hire opportunity .
- Successful ca! ndidate coordinates with fellow Engineers, Quality Assurance, Regulatory, and Marketing staff and group management in a matrix organization to establish and define design projects, prioritize and execute.
- Schedules projects by breaking up into interdependent tasks that can be organized and tracked using MS Project. Quantitatively track progress of design and development efforts relative to schedule and budgetary constraints.
- Leads design and development efforts from initial functional specification to manufacturing transfer.
- Effectively interfaces with all members of the group in response to solving design and technical problems, and leading staff to optimal cost effective solutions.
- Lead regular conference calls and visit with major suppliers to review project scheduling, product development, and supply chain topics.
- Writes specifications, risk assessments, design documentation, and validation/verification requirements in suppor! t of FDA/ISO Design Control requirements.
- Leads manuf! acturing transfer effort at the end of the design cycle. This includes technical support for vendors who provide a multitude of services such as plastic molding, machining, assembly, contract manufacturing, finishing etc.
- Coordinate in-field clinical testing of prototype and pre-production devices with industry professionals, including writing clinical test protocols and user feedback forms, and traveling to individual user sites for product training, test study setup, and follow up.
- Attend several annual Gastroenterology and Radiology trade shows as an exhibitor, interfacing directly with doctors, registered nurses, and technicians on new product ideas, design feedback, and Sales Team support.
- Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
- Assures all regulatory compliance issues are being foll! owed in the department’s activities, e.g. QSR and ISO.
- Create product labeling content, including user manuals and service manuals.
- Help conduct market research and existing intellectual property investigation.
- Bachelor of Science Degree in Electrical, Software or Mechanical Engineering
- Master’s Degree in Business Administration
- Over five years’ experience developing Class II devices for Gastroenterology and CT Colonography markets in an ISO 13485 Design Control environment.
- Excellent written and verbal communications skills.
- Knowledge of electrical or software or mechanical design processes, overseeing design effort to make sure that designs meet requirements.
- Experience in providing technical support in pursuit of FDA 510(k) applications and CE technical files. Understanding of FDA/ISO quality system requirements in both the design and manufacturin! g environments.
- Proficient in Windows based spreadsheet applic! ations in support of organizing and analyzing data. Must be able to quickly and accurately document activities using a Window based word processor. Advanced knowledge with windows based project scheduling and management program required.
Deirdre Middleton-The Judge Group
dmiddleton@judge.com
1-888-228-7162 x1581
http://www.linkedin.com/in/deirdremiddleton
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If you were eligible to this job, please email us your resume, with salary requirements and a resume to The Judge Group.
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This job starts available on: Sun, 31 Mar 2013 19:39:09 GMT
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