*POSITION- Medical Device engineer* *LOCATION- Phoenix,AZ | SALT LAKE CITY | SALT LAKE, UT,*
*Duration – 12 Month* Excellent Knowledge of Medical Device Design Control Requirements Update Design History File and Risk Management File Write Test Protocols and Test Results Good knowledge and understanding of ISO-13485 requirements Experience working with Venous Catheters, Ports desire. Identify all applicable documentation Identify missing documentation Baseline product Testing Creating an assessment of DHF gaps – All gaps are defined DIR and RM updates to support phase two testing Define extent of MDR/Complaint reduction activities that will happen in parallel Establish the detailed project plan Determine if and what MDR/Complaint reduction activities will be pursued with remediation Remediate the gaps Protocols (leverage “predicate” protocols to speed up writing)conditioning Testing Reports Process Validation and Component Qualification work Deliverables updates to reflect remediation activities Launch of any MDR/Complaint reduction changes *Atul Sharma* IDC Technologies, Inc Work: 408-418-5778 EXT-3027 Mailto: a...@idctechnologies.com *_____________________________________* *Empowering Technologies Services* Remote Services | IT Services | BPO | IT Consulting | Staffing Solutions | *_____________________________________*
