Manufacturing Engineer II - Medical Devices, Lean & GMP

Freudenberg Group; Jeffersonville (KY); On-site; USD 90,000 - 130,000; Full time

Job summary

Freudenberg Group is seeking an experienced Manufacturing Engineer to guide development and optimization of medical device production processes in a regulated environment. You will ensure ISO/GMP compliance, create robust work instructions, BOMs, and process flowcharts, and coordinate equipment qualification activities.

The role requires 3+ years in a regulated industry, strong problem-solving, and cross-functional collaboration to meet timelines, costs, and quality targets.

Qualifications

• Bachelor's degree in Engineering or related field.
• 3+ years in a regulated industry (medical devices).
• Experience with ISO 13485, ISO 14971, GMP principles.
• Knowledge of process validation and DOE studies.
• Familiarity with QC/QA documentation.

Responsibilities

• Lead development and optimization of manufacturing processes.
• Maintain manufacturing docs: BOMs, flowcharts, work instructions.
• Coordinate IQ/OQ/PQ of equipment and fixtures.
• Participate in production meetings and meet cost targets.
• Communicate with customers/suppliers on issues.
• Train operators and sustain improvements.
• Lead Lean/Six Sigma projects and Kaizen.
• Train new team members as needed.

Skills

Lean Six Sigma

Root cause analysis

Process optimization

Regulatory compliance

Cross-functional teamwork

Education

Bachelor's degree in Engineering

Tools

IQ/OQ/PQ

DOE

Process validation

Mold design

Job description

Freudenberg Group is seeking an experienced Manufacturing Engineer to guide development and optimization of medical device production processes in a regulated environment. You will ensure ISO/GMP compliance, create robust work instructions, BOMs, and process flowcharts, and coordinate equipment qualification activities.

The role requires 3+ years in a regulated industry, strong problem-solving, and cross-functional collaboration to meet timelines, costs, and quality targets.