Sr. Manufacturing Engineer - NPX

Nextern•Maple Grove, MN

4d•$100,000 - $140,000

About The Position

NPX Medical, a division of Nextern, is seeking an experienced Manufacturing Engineer to join its manufacturing team. NPX Medical specializes in precision metal components and assemblies, including nitinol engineered components, precision laser cutting and processing, and advanced catheter technologies. The role requires managing multiple complex projects while ensuring compliance with medical device industry standards and regulations. The ideal candidate has at least five years of medical device manufacturing experience and a record of improving manufacturing methods, systems, and processes to produce high-quality products. The engineer will lead manufacturing process development and validation, support and optimize production processes, maintain technical documentation, and design manufacturing fixtures, tooling, and equipment. The role also leads root-cause investigations and corrective and preventive actions, drives continuous improvement, and collaborates with Quality Assurance, R&D, and Production teams to support seamless product launches.

Requirements

Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical field.
At least 5 years of experience in medical device manufacturing engineering.
Proficiency in CAD software such as SolidWorks, AutoCAD, or similar.
Knowledge of statistical process control (SPC) and lean manufacturing.
Understanding of medical device validation processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Thorough understanding of ISO 13485:2016 Medical Device Quality Management System.
Experience with metal-based components, assemblies, and processing.

Responsibilities

Lead manufacturing process development and validation activities, including engineering protocols, IQ, OQ, and PQ reports, bills of materials, assembly instructions, manufacturing instructions, and procedures.
Troubleshoot and optimize medical device manufacturing processes to support efficient production while maintaining quality standards.
Write, review, and maintain manufacturing procedures, work instructions, SOPs, and process specifications in compliance with FDA regulations and ISO 13485 standards.
Design, develop, and implement manufacturing fixtures, tooling, and equipment, ensuring proper functionality and compliance with design controls.
Lead root-cause analysis investigations and implement corrective and preventive actions (CAPA).
Drive continuous improvement initiatives to enhance product quality, reduce waste, and improve manufacturing efficiency.
Collaborate with Quality Assurance, R&D, and Production teams to ensure seamless product launches.