Manufacturing Engineer - Injection Molding

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 site. This is a hands on role where you will spend real time on the production floor and see your work make a difference.

Applicants must be authorized to work in the United States without the need for employer-sponsored visa sponsorship, now or in the future.

Responsibilities:

• Own the full manufacturing process, from receiving materials through assembly, inspection, packaging, and release.
• Work through production issues on the floor with Operations and Maintenance, including equipment, tooling, fixtures, and operator workflow.
• Support new product introduction and design transfer, from pilot builds and ramp up through validated commercial production.
• Lead Engineering Change Orders, which means assessing their impact, planning the rollout, and coordinating validation and training.
• Run root cause investigations with tools like 5 Why, Fishbone, and DMAIC, and support CAPA activities.
• Drive continuous improvement with Lean, value stream mapping, and mistake proofing.
• Write and run equipment qualifications and process validations (IQ, OQ, PQ), along with Gauge R&R and capability studies.
• Keep controlled documentation current, including work instructions, BOMs, DMRs, DHR requirements, and control plans.
• Track and report KPIs such as yield, scrap, cycle time, downtime, and capacity.

Requirements:

• Bachelor’s degree in Industrial, Mechanical, or Manufacturing Engineering, or a related engineering discipline.
• 5-10 years of manufacturing engineering experience in medical device, injection molding, automated assembly, or another regulated environment is preferred.
• Hands on experience troubleshooting equipment and putting process improvements in place.
• Working knowledge of GMP, 21 CFR Part 820, and ISO 13485.
• Comfort with statistical analysis, including Cpk, Ppk, and control charts.
• Experience with ERP, MES, and document control systems.
• A self starting, detail focused approach, and the ability to juggle several projects in a busy environment.

Why work with us?

• Brand new facility located in the Fishers Life Sciences and Innovation Park
• Cafeteria onsite serving breakfast, lunch, and snacks - employees get a daily meal stipend
• 100% employer paid Dental and Vision benefits
• Modern space with brand new technology, climate-controlled production floor
• Opportunity for growth, development, and advancement
• 5 weeks (200 hours) of PTO, accrued throughout the year

We are an equal opportunity employer and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, veteran status, or any other legally protected status.