Manufacturing Engineer II — Medical Devices Lean Six Sigma

Freudenberg Medical; Jeffersonville (IN); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

401K Match

Diversity & Inclusion

Safe Environment

Corporate Events

Personal Development

Job summary

Freudenberg Medical LLC in Jeffersonville, IN is seeking a Manufacturing Engineer II to guide manufacturing process development, tooling design, and process characterization in compliance with ISO standards and GMP. Responsibilities include documenting BOMs, process flowcharts, SOPs; coordinating equipment IQ/OQ/PQ; and leading cross-functional teams to meet timelines, quality, and cost targets.

The role requires a Bachelor’s in engineering or related field, 3+ years in a regulated industry, and

Qualifications

• Bachelor's/University degree in Engineering, Chemistry, Biology, or related field.
• 3+ years' experience in a regulated industry.
• Experience with ISO 13485 and GMP in medical devices.
• Familiarity with DOE, IQ/OQ/PQ, and validation concepts.

Responsibilities

• Guide development and optimization of manufacturing processes per ISO and GMP.
• Create and maintain manufacturing docs: BOMs, flowcharts, work instructions, test plans.
• Coordinate procurement, installation, qualification of equipment.
• Participate in daily production meetings and coordinate with ops and customer service.
• Communicate with customers/suppliers on project matters and quality issues.
• Train technicians and operators through sustaining engineering.
• Use root-cause problem-solving to fix manufacturing issues and lead cross-functional teams.
• Lead Lean/Six Sigma projects to improve productivity and reduce waste.
• May help train new team members.

Skills

Root cause analysis

Lean Six Sigma

Cross-functional collaboration

Documentation

Education

Bachelor's degree in Engineering, Chemistry, Biology, or related field

Tools

BOMs

Process documentation

IQ/OQ/PQ

Job description

Freudenberg Medical LLC in Jeffersonville, IN is seeking a Manufacturing Engineer II to guide manufacturing process development, tooling design, and process characterization in compliance with ISO standards and GMP. Responsibilities include documenting BOMs, process flowcharts, SOPs; coordinating equipment IQ/OQ/PQ; and leading cross-functional teams to meet timelines, quality, and cost targets.

The role requires a Bachelor’s in engineering or related field, 3+ years in a regulated industry, and