Senior Catheter Process Engineer: From Lab to Launch

Pulse Biosciences, Inc.; Hayward (CA); Presencial; USD 130.000 - 155.000; Jornada completa

Descripción de la vacante

Pulse Biosciences, Inc. is seeking a Senior Process Development Engineer in Hayward, CA to bridge early catheter development and commercial manufacturing.

You will refine first‑in‑human devices into scalable, robust products with a manufacturing mindset and proven transfer success. Responsibilities include DFMA optimization, process validation support, supplier collaboration, and cross‑functional teamwork to meet regulatory and quality standards.

Formación

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, Manufacturing Engineering, or related field.

Responsabilidades

• Lead process development to transition early-stage catheter devices to commercially viable products.
• Perform DFM/DFA analyses and tolerance studies to reduce producibility risks.
• Develop component specs, drawing requirements, and inspection criteria per device needs.
• Characterize and optimize catheter manufacturing processes (extrusion, braiding, bonding, laser cutting).
• Develop electrical assembly processes for catheter components and manage ECOs for design transfer.
• Collaborate with QA, regulatory, and manufacturing to ensure compliance and timelines.

Conocimientos

Process development

Catheter manufacturing

DFM/DFA analysis

DOE (design of experiments)

Quality systems

Cross-functional collaboration

Educación

Bachelor’s degree in Mechanical Eng.

Master’s degree preferred

Herramientas

SolidWorks

GD&T (ASME Y14.5)

Minitab

Descripción del empleo

Pulse Biosciences, Inc. is seeking a Senior Process Development Engineer in Hayward, CA to bridge early catheter development and commercial manufacturing.

You will refine first‑in‑human devices into scalable, robust products with a manufacturing mindset and proven transfer success. Responsibilities include DFMA optimization, process validation support, supplier collaboration, and cross‑functional teamwork to meet regulatory and quality standards.