Manufacturing Engineer

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

Industry: Medical Devices (regulated manufacturing environment)

About the Role

The Manufacturing Engineer supports process readiness, engineering change execution, equipment qualification, and manufacturing documentation control to ensure efficient, compliant site operations in a regulated medical device manufacturing environment.

What You’ll Do

• Review and support site quality records, including NCRs, IEs, and CAPAs, driving root cause and corrective actions across manufacturing processes.
• Own and review ECRs, ECNs, routers, BOM updates, and work instructions, ensuring accurate and traceable engineering change execution.
• Walk production floor processes to assess readiness, identify risks, and define implementation requirements ahead of change rollout.
• Support equipment installation, qualification (OQ/PQ), validation, and decommissioning activities from protocol through execution.
• Draft and execute qualification/validation protocols and reports tied to manufacturing and equipment changes.
• Support MES readiness and manufacturing master data activities to enable production system accuracy.
• Manage engineering documentation and BOM/change activity through Windchill (or equivalent PLM/change management system).
• Support InfoPV equipment qualification work, including documentation, execution support, and traceability.
• Apply basic Gage R&R principles to evaluate measurement system capability, with hands‑on mentorship from a team lead to build applied expertise.
• Support development and maintenance of control plans to ensure manufacturing process consistency and regulatory compliance.
• Support Vault DMR updates and help maintain accuracy of controlled manufacturing documentation.
• Partner cross‑functionally with Operations and Quality to improve flow, efficiency, and manufacturability.

What You Bring

• Bachelor's degree in Mechanical, Manufacturing, Industrial, or a related engineering field.
• 3+ years of manufacturing engineering experience in medical device / regulated production: strong new grad candidates with relevant internship/co‑op experience will also be considered.
• Working knowledge of Windchill preferred; equivalent experience with another PLM/change management system accepted.
• Basic understanding of equipment qualification (OQ/PQ) and validation documentation.
• Familiarity with Gage R&R concepts - full training provided on‑site by team lead.
• Exposure to control plan development/maintenance.
• Experience with BOM updates, ECR/ECN process, and controlled document environments.
• Strong communication, cross‑functional collaboration, and attention to detail in a regulated setting.
• Open to local Warsaw, IN candidates and candidates willing to relocate.

Why choose us

• An international community bringing together more than 110 different nationalities
• An environment where trust is central: 70% of our leaders started their careers at the entry level
• A strong training system with our internal Academy and more than 250 modules available
• A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.