Catheter Sustaining/Verification Engineer

Catheter Sustaining/Verification Engineer
Duration:12+months
Location: Issaquah-WA

• Perform gap analysis of existing data in life cycle management to determine testing needed or provide rationalization for lack of compliance 
• Application of consensus standards for the single use catheter class three device. 
• Support development team with tasks as assigned. 
• Write protocols, conduct testing and write reports for DHF deliverables 
• Performs design verification testing as needed (DVT) for new product development and sustaining projects, troubleshoots, writes reports 
• Conduct failure investigation involving variety of destructive and nondestructive tools 
• Work with new vendors on qualification of new components and first article inspection 
• Support manufacturing changes 

Required Knowledge/Skills, Education, and Experience: 
• BS in Mechanical, Chemical, Industrial , Biomedical or other engineering fields 
• At least 5 years experience of single use Sterile medical device 
• Relevant technical experience in related field such as manufacturing , device development 
• Knowledge of relevant device standards (ISO, FDA, MDD, CFR 820) 
• Excellent leadership, interpersonal and communication skills 
• Ability to adapt to change and prioritize 
• Solid understading of Design Control and application of SOPs in medical device Lifecycle management 

Desirable Experience: 
• Remediation of Regulatory deficiencies 
• Sustaining and Life Cycle Management in a medical device environment 
• Statistics and use of Minitab 
• Design of Experiments 
• Packaging Engineering 
• Biocompatiblilty 
• Sterilization 
• Supplier Qualification

Thanks and Regards,
 
Ali Khan
APN Software Services, Inc.
39899 Balentine Drive, Suite 385, Newark, CA 94560 
Direct: 510.870.8798 | Fax: 510.623.5055 | ali@apninc.com 

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