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