Manufacturing Engineer- Medical Devices

Nextern•Maple Grove, MN

About The Position

We are seeking an experienced Manufacturing Engineer with a strong background in medical device production to join our dynamic manufacturing team. The ideal candidate will have 3+ years of experience in medical device manufacturing, with expertise in both electro-mechanical devices and single-use disposable products such as catheters. This role requires a versatile professional who can manage multiple complex projects while ensuring compliance with stringent medical device industry standards and regulations.

Requirements

Bachelor’s degree in manufacturing engineering, Mechanical Engineering, Biomedical Engineering, or related technical field
Minimum 3 years of experience in medical device manufacturing engineering
Proven experience with electro-mechanical device assembly and testing
Experience with single-use disposable medical devices (catheters, guidewires, or similar products)
Demonstrated experience with Epicor ERP system or similar enterprise resource planning software
Experience with FDA-regulated manufacturing environments
Proficiency in CAD software (SolidWorks, AutoCAD, or similar)
Knowledge of statistical process control (SPC) and lean manufacturing principles
Understanding of medical device design controls and validation processes
Experience with process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
Thorough understanding of FDA 21 CFR Part 820 Quality System Regulation
Knowledge of ISO 13485 Medical Device Quality Management System
Familiarity with ISO 14971 Risk Management for Medical Devices
Understanding of biocompatibility requirements (ISO 10993) for medical devices

Responsibilities

Design, develop, and optimize manufacturing processes for medical devices, including electro-mechanical assemblies and single-use disposable products such as catheters, ensuring efficient production while maintaining quality standards
Write, review, and maintain comprehensive manufacturing procedures, work instructions, Standard Operating Procedures (SOPs), and process specifications in compliance with FDA regulations and ISO 13485 standards
Design, develop, and implement manufacturing fixtures, tooling, and equipment for production of medical devices, ensuring proper functionality and compliance with design controls
Lead root cause analysis investigations, implement corrective and preventive actions (CAPA), and drive continuous improvement initiatives to enhance product quality, reduce waste, and improve manufacturing efficiency
Utilize Epicor ERP system to manage Bills of Materials (BOMs), routing operations, work orders, inventory management, and production planning activities
Work closely with Quality Assurance, Regulatory Affairs, R&D, and Production teams to ensure seamless product launches and manufacturing transfers
Ensure all manufacturing processes comply with FDA 21 CFR Part 820 (Quality System Regulation), ISO 13485, and other applicable medical device regulations
Provide technical support to production floor, troubleshoot manufacturing issues, and implement solutions to maintain production schedules and quality targets
Participate in design control activities including Design History Files (DHF), risk analysis, and validation/verification protocols
Train production personnel on new procedures and processes, and mentor junior engineering staff
Other duties and projects assigned