Manufacturing Engineer

Stevanato Group S.p.A.•Fishers, IN

10d

About The Position

The Manufacturing Engineer develops, maintains, and improves manufacturing processes across the full production lifecycle, from receipt of materials and component preparation through manufacturing, assembly, inspection, packaging, and release. The role provides hands-on engineering support for new product introduction, established production, engineering changes, and equipment and process improvements. In collaboration with Operations, Quality, Maintenance, Automation, Supply Chain, and Process Engineering, the Manufacturing Engineer ensures processes are safe, capable, efficient, documented, validated, and compliant with applicable medical device requirements. The position owns and supports end-to-end production processes, provides floor-level troubleshooting, supports design transfer and product ramp-up, and implements engineering changes and continuous improvements. It also defines and supports equipment, tooling, automation, and validation activities; maintains controlled manufacturing documentation and systems; and supports training for operators and technicians.

Requirements

Bachelor’s degree in Industrial Engineering, Mechanical Engineering, Manufacturing Engineering, or an equivalent engineering discipline.
Hands-on experience supporting routine production processes, troubleshooting manufacturing equipment, and implementing process improvements.
Experience with engineering change control, controlled documentation, risk assessment, validation, nonconformance investigation, and CAPA support.
Knowledge of Lean Manufacturing, value stream mapping, standard work, and continuous improvement methodologies.
Experience with process capability, statistical analysis, measurement system analysis, and data-based problem solving.
Solid knowledge of GMP, 21 CFR Part 820, ISO 13485, and applicable quality system requirements.
Strong computer skills, including Microsoft Office, ERP, MES, EAM, and document control systems.
Ability to read, write, and speak fluent English, with strong written and verbal communication skills.
Ability to prioritize and manage multiple production, improvement, and project deliverables in a fast-paced environment.
Strong problem-solving and critical-thinking skills; self-directed, detail-oriented, and comfortable working on the production floor.
Ability to work independently and collaboratively across Operations, Quality, Maintenance, Automation, Supply Chain, and Engineering.

Nice To Haves

Five or more years of manufacturing engineering experience in medical device manufacturing, plastic injection molding, automated assembly, or a comparable regulated manufacturing environment is preferred.
Experience with manufacturing equipment, automation, tooling, fixtures, and production line development is preferred.

Responsibilities

Own and support end-to-end manufacturing processes, including material flow, equipment setup, processing, assembly, inspection, testing, packaging, and product transfer or release.
Maintain understanding of process inputs and outputs, critical process parameters, quality characteristics, acceptance criteria, and interactions between operations.
Provide production-floor engineering support to resolve issues involving equipment, tooling, fixtures, materials, methods, automation, documentation, and operator workflow.
Work with Operations and Maintenance to reduce downtime, equipment failures, process interruptions, and production constraints.
Develop and maintain process flow diagrams, value stream maps, line layouts, standard work, capacity models, and manufacturing readiness assessments.
Support production planning and capacity decisions by evaluating equipment capability, staffing, tooling, bottlenecks, and demand requirements.
Ensure manufacturing processes remain validated and controlled during routine production.
Monitor and report manufacturing KPIs, including quality, yield, scrap, cycle time, production rate, downtime, capacity, and fulfillment.
Support design transfer and new product introduction from manufacturing concept through validated commercial production.
Provide design-for-manufacturability input and identify production risks, equipment and tooling needs, inspection methods, training needs, and capacity requirements.
Support pilot builds, production trials, ramp-up activities, and transfer to the ultimate manufacturing site.
Collaborate with customers and cross-functional teams on process capability, production issues, deviations, engineering changes, and improvement activities.
Initiate, assess, and implement Engineering Change Orders affecting materials, components, tooling, equipment, software, automation, process parameters, inspection methods, and manufacturing documentation.
Evaluate production, quality, validation, training, inventory, supplier, and regulatory impacts of proposed engineering changes.
Develop change implementation plans covering document updates, risk reviews, validation or verification, training, material disposition, and effective-date coordination.
Use structured problem-solving methods such as 5 Why, Fishbone, DMAIC, and data analysis to investigate deviations, nonconformances, equipment issues, and recurring process failures.
Support CAPA investigations and implement sustainable corrective and preventive actions in manufacturing.
Lead or support continuous improvement using Lean Manufacturing, value stream mapping, mistake-proofing, and waste-reduction methods; monitor results to confirm improvements achieve their intended outcomes.
Define requirements for manufacturing equipment, molds, tooling, fixtures, gauges, automation, and supporting utilities.
Coordinate equipment and tooling activities with internal departments, suppliers, and consultants to meet technical, cost, and schedule requirements.
Support equipment installation, startup, commissioning, and transfer into production.
Develop and execute equipment qualifications and process validations, including MVP, IQ, OQ, and PQ, as applicable.
Support test method validation and measurement system analysis, including Gauge R&R.
Apply statistical methods such as p-values, capability analysis, Cpk, Ppk, control charts, and data transformation to evaluate process performance and validation results.
Support preventive maintenance strategies, spare-parts planning, calibration requirements, and controls for reliable production.
Create, revise, and maintain controlled manufacturing documentation, including Manufacturing Instructions and Work Instructions, Bills of Materials (BOM), Device Master Records (DMR), Device History Record requirements (DHR), process flow diagrams, line layouts, and control plans.
Ensure documentation accurately reflects the approved production process and is updated before or concurrent with implementation of changes.
Maintain working knowledge of MES, LIMS, ERP, EAM, and document control systems used to manage production, quality, maintenance, materials, and records.
Support operator and technician training for new or revised processes, equipment, and documentation.