Injection Molding Manufacturing Engineer - Impact & Growth

Stevanato Group; Fishers (IN); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

5 weeks PTO

Job summary

Stevanato Group is hiring a Manufacturing Engineer to own and improve medical device manufacturing processes at our Fishers, Indiana site. This hands-on role requires you to work on the production floor and directly see the impact of your improvements.

You will drive process optimization, support new product introductions, manage Engineering Change Orders, and perform IQ/OQ/PQ validations, CAPA activities, and KPI tracking. Five weeks of PTO offered.

Qualifications

• Bachelor’s degree in Industrial, Mechanical, or Manufacturing Engineering.
• 5–10 years in manufacturing engineering in medical device or regulated environments.
• Hands-on equipment troubleshooting and process improvements.
• Experience with GMP, 21 CFR 820, ISO 13485.
• Comfort with SPC and control charts.
• ERP/MES/document control experience.

Responsibilities

• Own full manufacturing process from material receipt to release.
• Address on-floor production issues with Ops and Maintenance.
• Support new product introduction and ramp-up.
• Lead Engineering Change Orders with validation and training.
• Conduct root-cause investigations (5 Why, Fishbone, DMAIC) and CAPA.
• Drive continuous improvement using Lean and value stream mapping.
• Execute IQ/OQ/PQ, Gauge R&R, and capability studies.
• Maintain controlled docs: WIs, BOMs, DMRs, DHR, control plans.
• Track KPIs: yield, scrap, cycle time, downtime, capacity.

Skills

GMP knowledge

Statistical analysis

Lean manufacturing

Root cause analysis

Education

BEng in Industrial/Mechanical/Manufacturing

Tools

ERP systems

MES systems

Document control

Job description

Stevanato Group is hiring a Manufacturing Engineer to own and improve medical device manufacturing processes at our Fishers, Indiana site. This hands-on role requires you to work on the production floor and directly see the impact of your improvements.

You will drive process optimization, support new product introductions, manage Engineering Change Orders, and perform IQ/OQ/PQ validations, CAPA activities, and KPI tracking. Five weeks of PTO offered.