Sustaining / Process Engineer – Medical Device Manufacturing

About the role

AngioSafe, a Bay Area start‑up developing advanced catheters, is looking for a hands‑on Manufacturing/Process Engineer to support and scale production of its medical devices. The role is focused on ensuring reliable, cost‑effective manufacturing while maintaining regulatory compliance.

Key responsibilities

• Create, document, and validate new manufacturing processes for higher‑volume production.
• Support day‑to‑day line operations, troubleshoot equipment such as laminators, laser welders, and hot boxes, and resolve non‑conformances.
• Work directly on the production floor alongside assemblers to improve processes and quality.
• Monitor ongoing processes, develop assembly and test fixtures, and generate quality documentation (NCRs, CAPAs, deviations).
• Collaborate with suppliers to improve manufacturability, qualify new components, and reduce costs.

Required profile

• 5+ years of experience in a regulated medical‑device manufacturing environment.
• Hands‑on mechanical aptitude with direct experience operating production equipment.
• Ability to work independently in a fast‑paced, small‑company setting.
• Strong verbal and written communication skills.

Required skills

• Experience with lamination or laser welding processes.
• Proficiency in editing Manufacturing Procedures, Lot History Records, Bills of Materials.
• Comfort using inspection and test equipment (vision systems, tensile testing).
• SolidWorks knowledge (helpful but not required).