Manufacturing Engineer - Medical Device

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. This role requires a versatile professional who can manage multiple complex projects while ensuring compliance with stringent medical device industry standards and regulations. The ideal candidate will have 5+ years of experience in medical device manufacturing, demonstrating improved: manufacturing methods, systems and processes to produce a high-quality product.

Requirements

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

Responsibilities

Lead manufacturing process development and validation activities: engineering protocols, IQ, OQ, PQ reports, bill of materials, assembling instructions, manufacturing instructions and procedures.
Troubleshoot & Optimize manufacturing processes for medical devices ensuring efficient production while maintaining quality standards.
Write, review, and maintain 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.
Work closely with Quality Assurance, R&D, and Production teams to ensure seamless product launches.
Other duties and projects assigned.