Senior Medical Device Manufacturing Engineer

Nextern; Osseo (MN); Sur place; USD 85 000 - 120 000; Plein temps

Avantages offerts par ce poste

Health Plan

Retirement Plan

Paid Time Off

Life Insurance

Disability Insurance

Résumé du poste

NPX Medical, a division of Nextern, is seeking an experienced Manufacturing Engineer to join our medical device production team. You will manage multiple complex projects while ensuring compliance with FDA and ISO 13485 standards.

The ideal candidate has 5+ years in medical device manufacturing and a strong track record of improving methods and processes. You will lead process development, design fixtures and tooling, and collaborate across QA, R&D, and Production to deliver high-quality

Qualifications

• Bachelor's degree in manufacturing/related field.
• 5+ years in medical device manufacturing.
• Experience with ISO 13485 and FDA regulations.

Responsabilités

• Lead process development, validation activities: IQ/OQ/PQ, BOM, work instructions.
• Troubleshoot and optimize manufacturing processes for quality and efficiency.
• Write, review, and maintain SOPs and process specifications in compliance with FDA/ISO13485.
• Design and implement fixtures, tooling, and equipment for production.
• Lead root cause analyses and CAPA to drive continuous improvement.
• Collaborate with QA, R&D, and Production for smooth product launches.

Connaissances

CAD

SolidWorks

AutoCAD

SPC

Lean manufacturing

IQ/OQ/PQ

FDA/ISO13485

Root cause analysis

Formation

Bachelor's degree in Manufacturing Engineering

Outils

SolidWorks

AutoCAD

Description du poste

NPX Medical, a division of Nextern, is seeking an experienced Manufacturing Engineer to join our medical device production team. You will manage multiple complex projects while ensuring compliance with FDA and ISO 13485 standards.

The ideal candidate has 5+ years in medical device manufacturing and a strong track record of improving methods and processes. You will lead process development, design fixtures and tooling, and collaborate across QA, R&D, and Production to deliver high-quality