Sr. Manufacturing Engineer - NPX

Nextern•Maple Grove, MN

4d•$100,000 - $140,000

About The Position

NPX Medical, a division of Nextern, is a global, vertically integrated medical device development and manufacturing platform specializing in precision metal components and assemblies, nitinol engineered components, precision laser cutting and processing, and advanced catheter technologies. The company is seeking an experienced Manufacturing Engineer to join its manufacturing team. This role manages complex projects and supports the development and improvement of manufacturing methods, systems, and processes to produce high-quality medical devices while meeting applicable industry standards and regulations. The position leads manufacturing process development and validation, provides production process support and optimization, and maintains technical documentation compliant with FDA regulations and ISO 13485. It also involves designing and implementing fixtures, tooling, and production equipment; leading root-cause investigations and corrective and preventive actions; driving continuous improvement; and collaborating with Quality Assurance, R&D, and Production teams to support 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 or knowledge involving metal-based components, assemblies, and processing.

Responsibilities

Lead manufacturing process development and validation activities, including engineering protocols, IQ/OQ/PQ reports, bills of materials, assembly instructions, manufacturing instructions, and procedures.
Troubleshoot and optimize medical device manufacturing processes to support efficient production and maintain 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 support seamless product launches.