Test Mechanical Engineer for Medical DevicesPosted: November 10, 2009
ATS is an information technologies consulting company providing services to Fortune 500 companies nationwide. ATS specializes in providing full-service staffing solutions by providing technical and business personnel through staff supplementation and project engagements. The company has extensive contacts within its Fortune 500 client base and is able to access a large pool of talented and responsive professionals with proven records of accomplishment in both the technical and business fields.
We are currently seeking a Test Engineer for Medical Devices who will be primarily responsible for developing and implementing the most appropriate test methods to conduct design verification of products in accordance to international standards and regulations for medical devices. Position to include the design of, and/or purchase, as well as installation, and validation of required equipment to perform said tests.
Essential Duties and Responsibilities:
* Interfacing with product development teams to develop and implement the most appropriate test methods for conducting design verification testing.
* Lead, develop, and implement test equipment (hardware/software) and specifications as required.
* Develop all documentation associated test activities.
* Work with external test equipment suppliers as needed.
* Comply with all design related standards as developed by external regulatory groups such as ISO, FDA, etc.
* Comply with department and corporate quality initiatives.
Experience Level:
Unspecified
Requirements:
* BSME or BSEE with 5-10 years experience and/or training; or equivalent combination of education and experience.
* Strong knowledge of standards such as ASTM, UL, IEC 60601-1, ISO 8536-4 and ISO 10555-1 & -5
* Knowledge of GMP and other regulatory requirements
This description is an outline of the major recurring responsibilities of the job. It is not intended to be all inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.
ATS offers health coverage, 401K participation, Long Term Disability and Life Insurance. Please refer to job code 09-00634 when responding to this ad.
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