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Posted by: CCSI Inc - Robert Ryder <robert@ccsiinc.com> on October 15, 2009 at 07:10:08. Click here to reply to this post via Email.

Contract / Temp to Perm / Permanent: Contract
City: Mounds View
State: Minnesota
Country: United States

Design history file review to collect, review, and update as necessary, risk assessment and Design FMEA documentation on existing market released devices, Confirm and document traceability between objective evidence documentation and MDD Conformity requirements., Generate Declaration of Conformities., 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., 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., 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

Provide reliability engineering support of market released Pacemakers and Defibrillators. Focus of project is Medical Device Directive/Active Implantable Medical Devices Technical File update. Research of standards, tracing of compliance into Design history files, writing reports to show compliance, essential requirements matrices, declaration of conformity. May also support product through the product life cycle and/or specification updates or specification harmonization.