Medical Device Manufacturing Engineer (Catheters)

Nextern; Maple Grove (MN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health Plan

Retirement Plan

Paid Time Off

Birthday Holiday

Life Insurance

Family Leave

Disability Insurance

Taco Thursdays

Job summary

Nextern in Maple Grove, MN seeks an experienced Manufacturing Engineer for medical device production, focusing on electro-mechanical assemblies and single-use catheters. The role demands 3+ years in medical device manufacturing and strong process development skills.

You will optimize processes, write procedures, manage ERP (Epicor), support design controls and CAPA, and collaborate across QA, Regulatory Affairs, R&D and Production to assure FDA and ISO13485 compliance.

Qualifications

• Bachelor's degree in manufacturing/Mechanical/Biomedical Engineering or related field.
• 3+ years of experience in medical device manufacturing engineering.
• Experience with electro-mechanical device assembly and testing.
• Experience with single-use disposable medical devices (catheters, guidewires, etc.).
• Proficiency with CAD software (SolidWorks, AutoCAD).
• Knowledge of SPC and lean manufacturing principles.
• Familiarity with design controls and validation (IQ/OQ/PQ).
• FDA 21 CFR Part 820, ISO 13485, ISO 14971, ISO 10993 knowledge.

Responsibilities

• Design, develop, and optimize manufacturing processes for medical devices (electro-mechanical assemblies and catheters).
• Write, review, and maintain SOPs, process specs, and documentation per FDA/ISO requirements.
• Design fixtures and tooling for production of medical devices.
• Lead CAPA investigations and drive continuous improvement.
• Manage BOMs, routing, and production planning in Epicor ERP.
• Collaborate with QA, Regulatory Affairs, R&D, and Production.

Skills

Problem solving

Lean manufacturing

Root cause analysis

Troubleshooting

Project management

Education

Bachelor's degree in Manufacturing/Mechanical/Biomedical Engineering or related

Tools

SolidWorks

AutoCAD

Epicor ERP

Job description

Nextern in Maple Grove, MN seeks an experienced Manufacturing Engineer for medical device production, focusing on electro-mechanical assemblies and single-use catheters. The role demands 3+ years in medical device manufacturing and strong process development skills.

You will optimize processes, write procedures, manage ERP (Epicor), support design controls and CAPA, and collaborate across QA, Regulatory Affairs, R&D and Production to assure FDA and ISO13485 compliance.