FM Manufacturing Engineer II (Medical Devices)

Location: Jeffersonville, Indiana, United States

Company

hirify.global develops and manufactures medical device products and production solutions in regulated environments.

What you will do

• Develop and optimize manufacturing processes, tooling, and process characterization activities in compliance with ISO, GMP, and applicable regulatory requirements.
• Create and maintain BOMs, process flowcharts, work instructions, SOPs, production records, and test or inspection plans.
• Specify and coordinate the procurement, installation, and IQ/OQ/PQ qualification of manufacturing equipment, fixtures, and gauges.
• Collaborate with operations, customer service, customers, and suppliers to meet project timelines, production goals, quality requirements, and cost targets.
• Train and support technicians and operators through sustaining engineering activities.
• Lead root-cause problem solving, cross-functional corrective actions, Lean/Six Sigma projects, and Kaizen initiatives to improve productivity, quality, delivery, and cost.

Requirements

• Bachelor’s degree in engineering, chemistry, biology, or a related science or technical field.
• At least 3 years of experience in a regulated industry.
• Experience with medical device manufacturing processes, including equipment operation, injection molding, extrusion, catheter manufacturing, assembly, and relevant materials.
• Understanding of ISO 13485, ISO 14001, ISO 14971, GMP principles, and United States 21 CFR 820 requirements.
• Experience with process validation, process window and repeatability studies, DOE, IQ/OQ/PQ, product testing, and inspection methods.
• Ability to maintain technical documentation and apply formal problem-solving, critical-thinking, and deductive methods.

Culture & Benefits

• Full-time employment in a regulated medical manufacturing environment.
• Equal opportunity workplace committed to diversity and inclusion.