Hands-On Catheter Manufacturing Engineer

AngioSafe, Inc.; San Jose (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

AngioSafe, Inc. in the Bay Area seeks a hands-on Manufacturing/Process Engineer to support catheter production, drive process improvements, and ensure regulatory compliance. The role requires direct work on manufacturing equipment and a practical, manufacturing-focused mindset.

You will collaborate with operators, qualify processes, and help scale up high‑volume production. The position emphasizes close collaboration with production teams to optimize yield, reduce waste, and maintain

Qualifications

• 5+ years in medical device manufacturing.
• Hands-on experience with production equipment.
• Experience with lamination or laser welding.
• Editing MPs, LHRs, and BOMs.

Responsibilities

• Primary focus: Support the manufacturing line and advance the processes and device in order to support scale up.
• Create and document new manufacturing processes as necessary for production at significantly high volumes and validate as appropriate.
• Support ongoing manufacturing activities including dealing with production equipment, non‑conformances, facilities and other line related issues. This includes SOLVING issues with laminators, laser welders, hot boxes, etc.
• Spend significant time on the manufacturing line alongside the assemblers to improve processes and increase quality. You are the primary interface between engineering and production.
• Assist development of assembly and test fixturing with a focus on quality and volume.
• Write protocols & test reports related to validation activities.
• Collaborate with existing suppliers to improve manufacturability and decrease cost.
• Qualify components from new suppliers in order to improve supply chain flexibility.

Skills

Medical device manufacturing

Hands-on production equipment

Lamination

Laser welding

Process documentation

Quality assurance

Job description

AngioSafe, Inc. in the Bay Area seeks a hands-on Manufacturing/Process Engineer to support catheter production, drive process improvements, and ensure regulatory compliance. The role requires direct work on manufacturing equipment and a practical, manufacturing-focused mindset.

You will collaborate with operators, qualify processes, and help scale up high‑volume production. The position emphasizes close collaboration with production teams to optimize yield, reduce waste, and maintain