Manufacturing Engineer – Medical Devices, Process & Change

Amaris Consulting; Warsaw (IN); On-site; USD 70,000 - 95,000; Full time

Job summary

Amaris Consulting seeks a Manufacturing Engineer for a regulated medical device site in Warsaw, IN. You will support process readiness, engineering changes, equipment qualification, and master data maintenance to ensure compliant, efficient production.

The role requires a Bachelor's in engineering and 3+ years in medical device manufacturing, with familiarity in Windchill or similar PLM, OQ/PQ, BOM updates, and change control.

Qualifications

• Bachelor's degree in an engineering field is required.
• 3+ years of manufacturing engineering experience in medical device / regulated production; new grads considered with internship/co-op.
• Working knowledge of Windchill or similar PLM; familiarity with BOM/ECR/ECN processes.
• Basic understanding of equipment qualification (OQ/PQ) and validation documentation.
• Exposure to control plans and Gage R&R concepts; on-site training provided.

Responsibilities

• Review site quality records (NCRs, IEs, CAPAs) and drive root cause actions.
• Own ECRs/ECNs, routers, BOM updates and work instructions for traceability.
• Assess readiness on the production floor and define implementation requirements.
• Support equipment installation, qualification, validation, and decommissioning activities.
• Draft and execute qualification/validation protocols and reports for changes.
• Support MES readiness and manufacturing master data accuracy.
• Manage engineering documentation and BOM/change activity in Windchill or PLM.
• Provide guidance on Gage R&R and measurement system capability.

Skills

Manufacturing engineering

Regulatory compliance

Cross-functional collaboration

Documentation control

Gage R&R concepts

Education

Bachelor's degree in Mechanical/Manufacturing/Industrial Engineering

Tools

Windchill

Job description

Amaris Consulting seeks a Manufacturing Engineer for a regulated medical device site in Warsaw, IN. You will support process readiness, engineering changes, equipment qualification, and master data maintenance to ensure compliant, efficient production.

The role requires a Bachelor's in engineering and 3+ years in medical device manufacturing, with familiarity in Windchill or similar PLM, OQ/PQ, BOM updates, and change control.