Senior Manufacturing Technician, NPI

Responsibilities

• Perform manufacturing operations using documentation within the Quality Management System (QMS) in compliance with cGMP
• Assist Engineering with prototype builds to transition product cycles from Development to NPI to Manufacturing
• Assist in new product transfer to contract manufacturers, including staff training
• Contribute to the definition of MPIs, WIs, TPs, and DHRs
• Identify and support ECO changes and work with manufacturing engineering for implementation
• Support manufacturing for animal lab studies, including design verification and validation activities
• Assist in materials logistics, including receiving, inspection, stocking, and kitting
• Process RMAs and administrative field returns
• Contribute to operations initiatives to improve quality, reduce cost, and simplify processes

Requirements

• High School diploma or equivalent
• Minimum 5+ years of hands-on experience with prototyping, NPI, or direct manufacturing in a medical device environment
• Catheter development and production experience required
• Understanding of cGMP and ISO regulations
• Proficiency in Microsoft Office Suite
• Ability to lift 10-15 pounds

Preferred Qualifications

• Experience soldering small components under a microscope
• Technical knowledge of assembly and test of electronic equipment including software applications
• Experience in a fast-paced startup environment

About the Company

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation. The Company’s proprietary CellFX® nsPFA™ technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.