Manufacturing Engineer II | Medical Device Lean & Validation

Freudenberg; Jeffersonville (IN); Hybrid; USD 70,000 - 95,000; Full time

Job summary

Freudenberg in Jeffersonville, Indiana, seeks a Manufacturing Engineer II to guide the development and optimization of medical device manufacturing processes, including tooling design and process characterization under ISO and GMP standards. You will own documentation, equipment qualification, and lead cross-functional teams to meet timelines and cost targets.

You will drive Lean/Six Sigma projects, train technicians, and ensure correct production records and SOPs are maintained for ongoing

Qualifications

• Bachelor's degree in Engineering or related field.
• 3+ years' experience in a regulated industry.
• Experience in medical device manufacturing processes.
• Knowledge of ISO 13485, ISO 14001, ISO 14971 and GMP.
• Experience with process validation (IQ/OQ/PQ, DOE).
• Strong documentation skills (SOPs, work instructions, production records).

Responsibilities

• Guide development and optimization of manufacturing processes.
• Specify and coordinate the procurement, IQ/OQ/PQ of equipment.
• Participate in daily production meetings and collaborate with teams.
• Proactively communicate with customers and suppliers on project matters.
• Train technicians and operators through sustaining engineering activities.
• Lead Lean/Six Sigma projects to improve productivity, quality, delivery, and cost.

Skills

Root-cause analysis

Lean Six Sigma

Cross-functional teamwork

DOE knowledge

Education

Bachelor's degree in Engineering or related field

Job description

Freudenberg in Jeffersonville, Indiana, seeks a Manufacturing Engineer II to guide the development and optimization of medical device manufacturing processes, including tooling design and process characterization under ISO and GMP standards. You will own documentation, equipment qualification, and lead cross-functional teams to meet timelines and cost targets.

You will drive Lean/Six Sigma projects, train technicians, and ensure correct production records and SOPs are maintained for ongoing