Manufacturing Engineer II

Key Responsibilities

• Lead and support manufacturing transfer activities from outside vendors to internal manufacturing sites.
• Develop and execute transfer plans, timelines, and readiness activities to support successful production launch.
• Evaluate existing supplier manufacturing processes, tooling, fixtures, equipment, process controls, and documentation for transfer suitability.
• Partner with cross-functional teams to define manufacturing requirements, capacity needs, equipment needs, and production flow for in-house manufacturing.
• Create, revise, and maintain manufacturing documentation including: work instructions, routers, process flows, PFMEAs, control plans, equipment qualifications, validation protocols and reports.
• Coordinate equipment installation, qualification, and implementation for transferred processes.
• Identify process risks and implement mitigation plans to ensure quality and continuity of supply.
• Troubleshoot manufacturing issues during transfer, pilot builds, and production ramp-up.
• Analyze manufacturing performance data and drive improvements in yield, cycle time, throughput, scrap reduction, and overall process capability.
• Ensure transferred processes comply with internal quality system requirements and applicable regulatory requirements.
• Collaborate with supplier quality and sourcing teams to support knowledge transfer, documentation handoff, and transition planning.
• Support training of production personnel and ensure manufacturing processes are released in a controlled and sustainable manner.
• Drive continuous improvement initiatives using Lean, Six Sigma, and root cause analysis methodologies.
• Support change control activities related to process transfer, equipment implementation, and documentation updates.

Required Qualifications

• Bachelor’s degree in Engineering discipline
• Minimum of 3 to 5 years of engineering experience in manufacturing, process engineering, industrialization, or operations support
• Experience supporting manufacturing transfer, process transfer, new product introduction, or supplier-to-site transfer activities
• Knowledge of process validation, equipment qualification, and manufacturing documentation requirements
• Experience working in a regulated industry such as medical device, pharmaceutical, aerospace, or similar
• Strong problem-solving, project management, and cross-functional collaboration skills
• Strong written and verbal communication skills
• Ability to manage multiple priorities in a fast-paced manufacturing environment

Preferred Qualifications

• Experience in medical device manufacturing
• Familiarity with GMP, GDP, FDA, ISO 13485, and applicable regulatory requirements
• Experience with risk management tools such as PFMEA and control plans
• Experience with Lean manufacturing and continuous improvement methodologies
• Knowledge of statistical methods, process capability, and data analysis tools
• Experience with ERP/MRP systems and manufacturing execution systems
• Six Sigma certification or formal continuous improvement training
• Experience supporting pilot builds, line set-up, and production ramp