Senior Catheter & Balloon Manufacturing Engineer

Socket.dev; Maple Grove (MN); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health, Dental & Vision

Retirement Plan with Company Match

Paid Time Off & Personal Days

Birthday Holiday

Life Insurance

Short-Term & Long-Term Disability

Taco Thursdays

Job summary

Socket.dev seeks a Senior Manufacturing Engineer to lead catheter and balloon manufacturing processes in a medical device setting. You will own advanced process development, design transfer, and validation activities, partnering with R&D for scalable production, while ensuring compliance with FDA regulations and ISO 13485.

You will mentor junior engineers, optimize throughput with DOE/ SPC, and oversee ERP accuracy in BOMs, routing, and production planning, all in a fast-paced, regulated

Qualifications

• Bachelor's degree required in a engineering discipline; Master’s degree a plus.
• 7–10 years of medical device manufacturing engineering experience, hands-on with catheter/balloon processes.

Responsibilities

• Lead catheter/balloon process development, transfer, and CAPA initiatives.
• Own IQ/OQ/PQ validation strategies for new and existing processes.
• Drive NPI manufacturing readiness with R&D for scalable production.
• Author procedures, risk analyses, and design controls compliant with FDA/ISO.

Skills

Technical Leadership

Problem Solving

Project Management

Mentorship

Communication

Attention to Detail

Adaptability

Quality Mindset

Education

Bachelor's degree in Manufacturing/Mechanical/Biomedical Engineering

Master's degree in related field (plus)

Tools

SolidWorks

AutoCAD

Epicor ERP

Job description

Socket.dev seeks a Senior Manufacturing Engineer to lead catheter and balloon manufacturing processes in a medical device setting. You will own advanced process development, design transfer, and validation activities, partnering with R&D for scalable production, while ensuring compliance with FDA regulations and ISO 13485.

You will mentor junior engineers, optimize throughput with DOE/ SPC, and oversee ERP accuracy in BOMs, routing, and production planning, all in a fast-paced, regulated