Michael Kurz Email & Phone Number

Cleveland/Akron, Ohio Area

Ahrensburg, Germany

(Contracted through BRUNEL GmbH, Hamburg, Germany)• Researched existing test reports and literature, both English and German, to ensure quality and applicability to current product line.• Wrote summaries of existing test reports applying them to the current product line.• Aided in creation of new product file structure.• Aided in risk analysis of new knee implant development.

Warsaw, Indiana

(Contracted through ADECCO, Indianapolis, Indiana)Project UDI – Unique Device Identification Nov 2015 to Aug 2016• Initiated engineering changes to product drawings to include unique identification markings per FDA requirements.• Provided rationale that new markings on the product would not affect its usability.• Provided rationale for devices where new identification markings were not possible.Project Trident; Knees: Design History File (DHF) Remediation Jan 2014 to Nov 2015• Evaluated existing product DHF documentation to determine inconsistencies or lack of information within the DHF according to design control requirements (gaps) and to resolve those gaps. These documents include:o Design Control Traceability Matrix (DCTM) – tracks all user needs and design inputs, as well as design outputs and verification and validation activities to meet those needs and inputs.o Design Failure Modes and Effects Analysis (DFMEA) – identifies possible failure modes from all features of a design, and what those failures can lead too Design/Process Change Log – tracks all changes made to product design and determines if these changes affect existing design specifications, verifications, and validationso Gap Tracking Log – identifies gaps and records a plan and evidence of gap resolution• Updated existing or created new DCTMs• Solved gaps within DCTMs to meet design inputs and acceptance criteria via various methods, such as:o Functional Relationship Analysiso Similar Device Analysiso Clinical Performance Summaryo Complaint Search Analysis• Initiated engineering changes to product drawings to update process procedures through the evaluation of router reviews, assessing effect on verification and validation.