Manufacturing Engineer

HuFriedyGroup•Northbrook, IL

14d•$75,000 - $100,000

About The Position

The Manufacturing Engineer provides engineering support to manufacturing operations through production line support, continuous improvement, capacity improvements, and new product transfers. The role improves manufacturing efficiency by optimizing human work factors, quality control, and material flow, and by identifying improvement opportunities using statistical methods and root cause analysis. The position supports machinery and production processes, troubleshoots equipment and operational problems, and helps resolve production and customer issues through corrective and preventive actions. It also drives improvements in yield, quality, cycle time, cost, and ergonomics; evaluates manufacturing capacity; and coordinates tooling, fixture, and equipment planning, procurement, installation, and qualification. For new product transfers, the engineer works with product development engineering to incorporate lessons learned, support capable and efficient operations, create or evaluate process documentation, and train operations personnel on new processes. The role also prototypes manufacturing concepts and product design changes and participates in Kaizen events.

Requirements

Bachelor of Science in Engineering; Mechanical, Chemical, Electrical, or Manufacturing Engineering is preferred.
At least two years of Manufacturing Engineering experience.
Familiarity with ISO 13485, FDA Design Control, CAPA, SCAR, and audit procedures.
Experience with structured problem-solving and statistical tools.
Training and experience in Lean and Six Sigma, or equivalent.
Experience with Design for Manufacturing, DFMEA, PFMEA, DOE, and validations.

Nice To Haves

Manufacturing Engineering experience in the medical device manufacturing industry.
CAD experience, preferably SolidWorks.

Responsibilities

Provide general oversight and monitoring of machinery, coordinating maintenance, upgrades, and repairs as needed.
Troubleshoot manufacturing process problems and provide hands-on technical support for manufacturing equipment and processes.
Assist with CAPA to resolve production and customer issues, using root cause analysis and following through on corrective actions.
Assist with formal failure analysis and issue resolution to ensure preventive actions are completed.
Prepare written documents, test plans, and reports when requested, including qualifications, risk assessments, and work instructions.
Provide operations with technical support to meet manufacturing quality and quantity objectives.
Lead continuous improvement initiatives to optimize yield, quality, cycle time, and ergonomics.
Conduct time studies, reduce cycle time, and assist with cost-reduction initiatives.
Assist with lean transformations on manufacturing lines and in supporting areas.
Identify process improvement opportunities, develop technical solutions, and troubleshoot manufacturing issues.
Investigate defect root causes and work with vendors and internal manufacturing teams to improve quality.
Assess and monitor manufacturing capacity against demand and recommend capacity improvements.
Specify tooling, fixtures, and equipment needed to meet capacity requirements, and coordinate their planning, procurement, installation, and qualification.
Perform Installation Qualification, Operational Qualification, and Performance Qualification.
Work with product development engineering to incorporate lessons learned during product development.
Evaluate and advise product development teams to support the introduction of capable and efficient operations.
Create, evaluate, and release process documentation for new processes.
Train operations personnel on new processes.
Prototype assembly and manufacturing concepts and product design changes.
Participate in Kaizen events.