Lead Catheter & Balloon Manufacturing Engineer

Nextern

Maple Grove (MN)

Hybrid

USD 100,000 - 130,000

Full time

14 days+

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Benefits offered by this job

Health care plan

Retirement match

Paid time off

Birthday holiday

Lifetime membership

Life insurance

Family leave

Disability insurance

Taco Thursdays

Job summary

Nextern in Minnesota seeks a Senior Manufacturing Engineer with 7–10 years of hands‑on medical device manufacturing experience, specializing in catheter and balloon catheter processes. You will drive process development, transfer to production, and continuous improvement with minimal supervision.

You will ensure FDA/ISO compliance, author procedures, mentor junior engineers, and lead評価 calibration and validation efforts.

Qualifications

7+ years in medical device manufacturing engineering, with hands‑on catheter/balloon experience.
Experience leading process validations and design transfers in FDA environments.
Advanced proficiency in CAD software and statistical methods; knowledge of ISO 13485 and ISO 14971.

Responsibilities

Serve as senior SME for catheter/balloon manufacturing (balloon forming, extrusion, bonding).
Design, develop, and optimize complex manufacturing processes applying DOE, SPC, and lean methods.
Lead readiness activities for new products, partnering with R&D to transfer designs.
Author/approve procedures, SOPs, and process specs; lead risk analyses and validation protocols.
Develop and qualify fixtures and automated equipment for catheter/balloon assembly.
Own IQ/OQ/PQ validation strategy for processes and equipment.
Lead CAPA initiatives and drive continuous improvement on the floor.
Oversee ERP BOMs, routing, WOs, inventory, and production planning in Epicor.