Hi Associates, Hope you are doing great...!!!
*QA with Validation EngineerLocation: Batesville, IN Duration: 7+ Months Contract* *Max Rate : $40/hr on C2C* *REQUIRED: *Strong experience with Systems Level verification and Test Engineering for electromechanical product designs. Broad level knowledge of Systems Test / V&V processes for related products is desired. Experience in leading system development or V&V in at least two of: mechanical, electrical and software (requires experience with Mechanical or Electronic design aspects. Software related V&V knowledge is helpful too, but candidates purely focused on Software Testing will not be a fit.) Medical Device industry experience Candidates should have the ability to "understand designs and then develop a way to test them/figure out what needs to be tested. Experience just executing the testing for test assets that other Test Engineers develop is not enough". Strong organizational and planning skills BS Degree in Engineering Minimum 2 years experience working in cross functional teams consisting of discipline specific design engineers (Mechanical, Electrical & Software Engineers) *ESSENTIAL DUTIES AND RESPONSIBILITIES* Review use cases and requirements for products to ensure that they can be verified and validated, including risk mitigations and usability requirements Work with New Product Development (NPD) teams to understand the product configurations being developed Support NPD teams in the completion of development testing and analysis, to characterize designs, understand margins, and use analysis for verification. Identify the statistical rationale and objective evidence data that will be required to show that all configurations of the product meet their requirements, as well as the customer needs Develop detailed strategic and tactical plans for gathering, analyzing and interpreting the identified data Document the reusable procedures that will be followed to efficiently gather the required data. Ensure procedures are traced to requirements and user needs Define and develop test fixtures in conjunction with test lab. Ensure that all fixtures are appropriately validated. Identify and document test unit configuration requirements. Ensure that enough product is available in the right configurations to complete testing. Work with testing facilities, both internal and external, to ensure that space and other required resources are available. Oversee the gathering of test data, either internally or with external partners. Review and statistically analyze gathered data and document pass/fail conclusions. Ensure that documented conclusions are traced to requirements and that all original data is retained. Ensure that all failed conclusions are documented to ensure the failure is appropriately reviewed, analyzed and corrected Measure and report on progress toward completion of verification and validation Summarize the verification and validation performed, the data reviewed, and conclusions reached in compliance with FDA and other regulatory requirements Development of verification for a medical device electromechanical product. May also include development and execution of system level verification and/or validation or Integration Test Planning. Verification & Validation planning Verification & Validation asset creation (scripts, protocols, datasheets) Mentoring design engineers and junior staff members in best practices for module level verification Verification & Validation data review Verification & Validation reporting Traceability Creation of detailed documentation in a regulated environment for Test Plans, Test reports, test procedures, test protocols *Thanks & Regards* *Anthony Michael * *Voice:* 201-257-5081 ext 163 *Email*: [email protected] *G-mail* : anthony.catamerica *Note: We are working with the Preferred Vendor.* -- You received this message because you are subscribed to the Google Groups "IT provider" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/it-provider. For more options, visit https://groups.google.com/groups/opt_out.
