Job Code : 10003
Category : Engineer
Type : Contract to Hire
· Responsible for compliance to applicable business policies and procedures.
· Investigates reported product experiences and complaints, work with a cross-functional team to accurately diagnose potential probable cause(s); systematically eliminate alternatives; document investigation results and conclusions; follow-up as necessary and timely closure of complaints.
· Conducts Device History Record (DHR) Reviews and documents the results
· Responsible for MDR and Adverse Event reporting activities.
· Provides input to management on new product failure modes, which may encompass manufacturing process change or design change.
· Generates complaint reports and charts to identify and communicate trends of product issues and appropriate actions to address.
· Interacts with other functions to complete post-market risk assessment activities.
· Provide training to internal and external customers as needed.
· Participate in on-call activities; support 24/7/365 call center where off-hour, weekend and holiday coverage may be required
· Other duties and responsibilities as assigned.
· Bachelor’s degree in engineering, related field or physics.
· 5+ Years of experience
· Understanding of active implantable devices, preferably neuromodulation systems.
· Working knowledge of Quality System requirements, including FDA GMPs and ISO 13485 and documentation procedures.
· Familiarity with personal computer software including work processing, spreadsheet, and statistical programs; computer aided drawing and project scheduling software preferred
· Problem solving tools including 5 whys, Fishbone, Design of Experiments, Data analysis, etc.