Manufacturing Engineer II

At Nextern, we inspire with passion, impact with significance, and act with integrity.. Nextern partners with OEMs, clinicians, and innovators to design, develop, and manufacture world-class medical devices across the full product lifecycle. From single-use disposables to fully integrated systems to precision components, our teams work as an extension of yours to solve patient needs and improve lives worldwide.

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.

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

Requirements

• Required: Bachelor’s degree in a STEM related 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