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Location: Indianapolis, IN | Schedule: Full-time, on-site

Overview

An established manufacturer of electronics and mechanical assemblies is seeking a Manufacturing Engineer to develop, implement, validate, and optimize production processes. This role supports new product introduction (NPI), process development, and continuous improvement initiatives that strengthen productivity, quality, safety, and cost efficiency across the operation.

What you'll do

• Analyze and optimize manufacturing processes to improve efficiency, quality, safety, and cost performance
• Develop, document, validate, and maintain manufacturing procedures, work instructions, process flows, and engineering documentation
• Lead continuous improvement initiatives using Lean Manufacturing, Six Sigma, Kaizen, 5S, SPC, and other operational excellence methodologies
• Perform root cause analysis and failure investigations, and implement corrective and preventive actions (CAPA)
• Design, develop, and implement manufacturing fixtures, tooling, and assembly processes for electronics and mechanical assemblies
• Support assembly operations involving soldering, epoxy dispensing, electromechanical assembly, and related processes
• Collaborate with production, quality, supply chain, engineering, vendors, and customers to resolve technical issues and improve manufacturing performance
• Establish process controls, collect and analyze production data, develop labor standards, and monitor key manufacturing metrics
• Support installation, qualification, and validation of new manufacturing equipment and capital projects
• Lead new product introduction (NPI) activities, ensuring successful transfer of products from design into production
• Develop and maintain APQP documentation including Process Flow Diagrams (PFD), PFMEA, Control Plans, MSA studies, and process validation protocols
• Conduct capability studies and equipment/process qualifications including IQ, OQ, and PQ activities
• Support compliance with ISO 9001, ISO 13485, and applicable regulatory requirements
• Identify and implement automation solutions to improve manufacturing throughput, consistency, and product quality

Required qualifications

• Minimum 5 years of Manufacturing Engineering experience in a production environment
• Medical device manufacturing experience required
• Experience supporting mixed electronics and mechanical assembly manufacturing operations
• Hands-on experience with assembly processes including soldering, epoxy application, tooling, fixtures, and manufacturing equipment
• Experience with process validation, process control, and manufacturing documentation systems
• Proven success leading continuous improvement and cost reduction initiatives
• This position requires use of information subject to the International Traffic in Arms Regulations (ITAR); candidates must be U.S. persons or protected individuals within the meaning of ITAR, defined as a U.S. Citizen, U.S. Permanent Resident ('Green Card Holder'), U.S. Temporary Resident, Political Asylee, or Refugee
• Knowledge of Lean Manufacturing and Six Sigma methodologies
• Familiarity with APQP, PFMEA, Control Plans, SPC, MSA, CAPA, and Root Cause Analysis
• Experience with process validation methodologies including IQ/OQ/PQ
• Experience with manufacturing automation and equipment integration
• Experience with ERP/MRP systems and production planning tools
• CAD software experience
• Statistical analysis and process capability evaluation skills
• Proficiency in Microsoft Office Suite
• Strong problem-solving capabilities
• Proficient in English (reading, writing, and verbal skills)
• Effective interpersonal and team leadership skills
• Good verbal and written communication skills
• Sound judgement and decision-making ability
• Ability to communicate and implement change
• Bachelor of Science in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or related technical discipline

Preferred qualifications

• Experience supporting high-volume manufacturing environments preferred
• SolidWorks experience preferred

Why this role

This position offers technical leadership and hands-on involvement across process development, quality systems, and new product introduction, working cross-functionally to build scalable, efficient manufacturing processes that support business objectives and customer requirements.