Production Engineer

We are seeking two Manufacturing Engineers for an expanding manufacturing facility in Indianapolis. These positions will involve providing engineering support for electrical, electronic, and mechanical assembly operations, with one role focusing on assembly support and another serving medical device customers.Duties• Enhance manufacturing processes for electronics and electromechanical assembly• Manage new product introduction (NPI) and transition products from design to production• Generate work instructions, process flows, procedures, validation protocols, and engineering documentation• Assist with soldering, epoxy dispensing, tooling, fixtures, assembly equipment, and automation• Develop APQP documentation, such as PFMEA, Control Plans, process flow diagrams, and MSA studies• Conduct IQ/OQ/PQ qualifications, capability studies, process validation, and process control• Lead root cause investigations, CAPA, and continuous improvement endeavors• Apply Lean, Six Sigma, Kaizen, SPC, and 5S techniques to enhance quality, safety, cost, and throughput• Collaborate with production, quality, engineering, supply chain, and suppliers to address manufacturing challenges• Uphold ISO 9001, ISO 13485, and relevant quality and regulatory standardsRequirements• Practical experience in manufacturing engineering within a production setting• Previous involvement in medical device manufacturing is a must• Background in supporting electronics and electromechanical assembly processes• Familiarity with NPI, process validation, PFMEA, Control Plans, CAPA, SPC, and MSA• Knowledge of IQ/OQ/PQ and regulated manufacturing processes• Proficiency in developing tooling, fixtures, and manufacturing processes• Bachelor’s degree in Manufacturing, Mechanical, Industrial Engineering, or a related field• CAD proficiency is necessary; SolidWorks knowledge is preferred• This role involves access to information subject to U.S. export control regulations, including ITAR. Employment is contingent upon compliance with applicable export control requirements and necessary authorizations.