Manufacturing Engineer

We are recruiting two Manufacturing Engineers for a growing Indianapolis manufacturing operation. These roles will provide hands-on engineering support for electrical, electronic, and mechanical assembly operations, including one urgent opening focused on assembly support and another supporting key medical device customers.

Responsibilities
• Develop and improve manufacturing processes for electronics and electromechanical assembly
• Lead new product introduction (NPI) and transfer products from design into production
• Create work instructions, process flows, procedures, validation protocols, and engineering documentation
• Support soldering, epoxy dispensing, tooling, fixtures, assembly equipment, and automation
• Develop APQP documentation, including PFMEA, Control Plans, process flow diagrams, and MSA studies
• Perform IQ/OQ/PQ qualifications, capability studies, process validation, and process control
• Lead root cause investigations, CAPA, and continuous improvement efforts
• Apply Lean, Six Sigma, Kaizen, SPC, and 5S methods to improve quality, safety, cost, and throughput
• Partner with production, quality, engineering, supply chain, and vendors to resolve manufacturing issues
• Support ISO 9001, ISO 13485, and applicable quality and regulatory requirements

Qualifications
• Hands-on manufacturing engineering experience in a production environment
• Medical device manufacturing experience required
• Background supporting electronics and electromechanical assembly processes
• Experience with NPI, process validation, PFMEA, Control Plans, CAPA, SPC, and MSA
• Working knowledge of IQ/OQ/PQ and regulated manufacturing processes
• Experience developing tooling, fixtures, and manufacturing processes
• Bachelor's degree in Manufacturing, Mechanical, Industrial Engineering, or a related technical field
• CAD experience required; SolidWorks preferred
• This position requires access to information subject to U.S. export control regulations, including ITAR. Employment is subject to compliance with applicable export control requirements and any required authorizations.