Manufacturing Engineer

Title: Manufacturing Engineer Job Category: CMP Operations Requisition Number: MANUF002007 Job Type: Full-Time Indianapolis, IN, 46250, United States Description What You'll Do Design and develop manufacturing processes for medical devices Lead design transfer from engineering into production Troubleshoot and solve real-world manufacturing and equipment challenges Improve processes using Lean manufacturing and continuous improvement methods Partner with engineering, quality, supply chain, and suppliers Support validation, verification, and risk management activities Create and maintain critical documentation (DHF, DMR, DHR, work instructions) Ensure compliance with FDA, ISO 13485, MDSAP, and CE requirements Analyze data to support process capability and improvement decisions Lead multiple engineering projects from concept through completion Help ensure products are designed for manufacturability and scalability What We're Looking For Required: Bachelor's degree in Mechanical, Biomedical, or related engineering field or equivalent combination of education and experience, with at least 1 year of engineering experience (medical device experience preferred). Strong problem-solving and technical troubleshooting skills Experience with manufacturing processes and/or product development Ability to manage multiple projects and priorities Preferred: Experience in regulated industries (FDA / ISO 13485) SolidWorks or similar CAD experience Background in Lean manufacturing or continuous improvement Experience with validation, verification, and process control What Makes You Successful in This Role You think critically and solve problems at the root cause You take ownership of projects from start to finish You balance detail-oriented documentation with hands-on execution You enjoy working cross-functionally across engineering and operations You are motivated by improving how things are made You thrive in fast-paced, highly regulated environments Work Environment & Schedule This is an on-site role working in a manufacturing facility, engineering lab, cleanroom, and office environment. Some physical activity is required. Limited travel (0-5%). Why Join Us? Help design and manufacture products that improve and save lives Work on meaningful engineering challenges every day Be part of a collaborative, hands-on engineering team Opportunity to grow in both technical and leadership paths See your work move directly from concept to production Equal Opportunity Employer We are an equal opportunity employer and value diversity at all levels of the organization. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, disability, or any other protected status. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.