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Posted by: CCSI Inc - Robert Ryder <robert@ccsiinc.com> on September 21, 2009 at 14:35:12. Click here to reply to this post via Email.

Contract / Temp to Perm / Permanent: Contract
City: Redmond
State: Washington
Country: United States

22562- Confirm and document traceability between objective evidence documentation and EN IEC 60601-1 standard requirements and all relevant standards. Diagnostic and therapeutic medical devices and device programmers. Assure the timely, accurate and independent evaluation of product performance and safety prior to clinical studies or market release. Provide support for released products, evaluate field performance and recommend corrective action when necessary., Prepare, review and approve Qualification Test Plans and Reports for assigned projects., Provide technical support for technicians performing the testing. Assure the resolution of all issues raised by the testing., Review and approve changes to products in production for reliability impact to aid in the correction of process, design or materials problems. ,Support Materials Quality Engineering by providing reliability input in the evaluation of discrepant material and in the qualification of new material to assure that device reliability requirements are met.,Support Regulatory Affairs by providing reliability input in the evaluation of MDRs and submissions of requests for approval to the FDA, Maintain expertise in international safety standards and serve as a resource to assist in the development of products that meet all international requirements., May supervise technicians and/or engineers.

Job is principally conducting design verification activities for external defibrillator/monitors. Focus is on Hardware (mechanical and electrical) as opposed to software. Core tasks include reviewing design changes for selection of appropriate design verification activities. Creating verification test plans, coordinating verification execution, interfacing with development teams and creating verification reports. Good verbal, written and interpersonal skills are essential.