Manufacturing Engineer

Industry: Medical Devices (regulated manufacturing environment)

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.

• 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.

• 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.

• 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 (after works, 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.