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 report
• Support process development, process characterization, and process validation activities including equipment IQ and Process OQ, and PQ, as applicable.
• 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.

Key Competencies:

• Technical leadership
• Manufacturing process development
• Project execution
• Cross-functional collaboration
• Risk identification and mitigation
• Problem solving and root cause analysis
• Documentation and change management
• Continuous improvement mindset

Years’ Experience Required: 3-5 years of relevant experience providing manufacturing transfer support