Lead Catheter Process Manufacturing Engineer

Adagio Medical Inc.; Laguna Hills (CA); On-site; USD 160,000 - 180,000; Full time

Job summary

Adagio Medical Inc. is seeking a Principal Catheter Process Manufacturing Engineer to lead the development, optimization, validation, and scaling of complex catheter manufacturing processes.

You will serve as the SME for catheter technologies, guiding NPI through commercial production and collaborating with R&D, Quality, Regulatory, Supply Chain, and CMOs/CDMOs. The role requires leadership across prototyping, clinical to mass production, with emphasis on process validation, DOE, and continuous

Qualifications

• BS in Engineering; Master’s degree a plus.
• 10+ years of medical device manufacturing engineering experience with Class II/III devices (high-volume precision Catheter manufacturing).
• Experience leading manufacturing process development, validation, and commercialization.
• Experience with CMOs/CDMOs and global partnerships.

Responsibilities

• Lead development, optimization, validation, and commercialization of catheter manufacturing processes.
• Design scalable processes for prototype, clinical, pilot, and commercial production.
• Provide technical leadership for complex catheter assembly including shaft, braiding, lamination, reflow, heat shrink, adhesive bonding, laser processing, tip assembly, pull‑wire integration, steering mechanisms.
• Develop and implement manufacturing strategies to improve quality, throughput, capacity, and cost.
• Lead process validation activities (IQ/OQ/PQ), DOE, Gage R&R, and SPC.
• Drive continuous improvement (First-pass yield, scrap reduction, cycle time, OEE).
• Lead design transfer, scale‑up, and technology transfer to CMOs/CDMOs; ensure compliance.
• Prepare manufacturing readiness plans, capacity models, and production strategies.

Skills

Polymer Processing & Thermal Forming

Braiding, Lamination & Reflow

Precision Adhesive Bonding

Process Validation (IQ/OQ/PQ)

Design of Experiments (DOE)

Statistical Process Control (SPC)

Lean Manufacturing & Six Sigma

Root Cause Analysis & Risk Management

Manufacturing Automation

Process Capability (Cp/Cpk)

FDA, ISO 13485, ISO 14971 & GMP

Strategic Manufacturing Leadership

Cross‑Functional Collaboration

Technical Mentorship

Data‑Driven Decision Making

Analytical & Problem-Solving

Education

BS in Engineering (Mechanical, Biomedical, or Manufacturing)

Job description

Adagio Medical Inc. is seeking a Principal Catheter Process Manufacturing Engineer to lead the development, optimization, validation, and scaling of complex catheter manufacturing processes.

You will serve as the SME for catheter technologies, guiding NPI through commercial production and collaborating with R&D, Quality, Regulatory, Supply Chain, and CMOs/CDMOs. The role requires leadership across prototyping, clinical to mass production, with emphasis on process validation, DOE, and continuous