Senior Catheter & Balloon Manufacturing Engineer

Nextern

Osseo (MN)

On-site

USD 100,000 - 130,000

Full time

37 hours ago

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Benefits offered by this job

Health Care Plan (Medical, Dental &amp

Wellness Resources

Retirement Plan with Company Match

Paid Time Off, Personal Days, AND

Birthday Holiday

Life Insurance

Family Leave

Disability Insurance

Taco Thursdays!!!

Job summary

Nextern seeks a Senior Manufacturing Engineer with 7–10 years in medical device manufacturing, focusing on catheter and balloon catheter processes such as balloon forming, extrusion, tipping, bonding, and related assembly. The role is a technical leader with no direct reports.

You will drive process development, design transfers, and validation activities using DOE, SPC, and lean methodologies to improve first-pass yield and throughput, while mentoring junior engineers and ensuring regulatory

Qualifications

Bachelor's degree in a STEM field; Master’s a plus.
7+ years in medical device manufacturing engineering with catheter/balloon experience.
Experience with FDA-regulated manufacturing, process validation, and design transfers.
Advanced CAD skills and SPC/DOE lean methods; IQ/OQ/PQ exposure.

Responsibilities

Serve as senior SME for catheter/balloon manufacturing incl. forming, extrusion, tipping, bonding, and RF/laser welding.
Design, develop, and optimize complex manufacturing processes; apply DOE and lean to improve yield.
Lead manufacturing readiness activities and transfer designs to scalable production.
Create and approve procedures, risk analyses, and validation protocols per FDA/ISO.
Lead validation strategy for new equipment and processes; mentor junior engineers.
Coordinate with QA, Regulatory, R&D, and suppliers on qualifications.
Ensure compliance with FDA 21 CFR Part 820 and ISO 13485.