Sustaining/Process Engineer

About the Company

AngioSafe is a Bay Area start-up focusing on improving healthcare delivery through state-of-the-art catheter development. Our seasoned experts are committed to producing high quality and innovative products to decrease risk and improve outcomes of arterial disease.

Responsibilities

• Support the manufacturing line and advance processes to support scale up
• Create, document, and validate new manufacturing processes for higher volumes
• Resolve production equipment issues including laminators, laser welders, and hot boxes
• Work alongside assemblers on the manufacturing line to improve processes and quality
• Assist in the development of assembly and test fixturing
• Write protocols and test reports related to validation activities
• Collaborate with suppliers to improve manufacturability and decrease costs
• Qualify components from new suppliers to improve supply chain flexibility

Requirements

• 5+ years of experience in a medical device manufacturing environment preferred
• Hands-on mechanical aptitude with direct experience working on production equipment
• Solid experience with lamination or laser welding
• Proven experience editing Manufacturing Procedures (MPs), Lot History Records (LHRs), and Bills of Materials (BOMs)
• Experience working within a highly regulated environment
• Strong verbal and written communication skills

Preferred Qualifications

• Proficiency in SolidWorks
• Experience using inspection and test equipment such as vision systems and tensile testing