Manufacturing Engineer II – Medical Devices, ISO/GMP

Freudenberg; Jeffersonville (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

Freudenberg Manufacturing Engineer II role in Indiana supports medical device production. The candidate will work on regulated processes, ensuring quality and compliance across molding, extrusion, catheter manufacturing, and assembly.

We seek a professional with ISO 13485 knowledge, GMP experience, and strong documentation practices to maintain robust production records and support process validation activities.

Qualifications

• Bachelor's degree or higher in Engineering or related field.
• 3+ years in a regulated industry.
• Experience with molding, extrusion, catheter manufacturing, and assembly.
• Thorough understanding of ISO standards, GMP principles, and regulatory requirements.
• Knowledge of process validation methods, DOE, IQ/OQ/PQ.
• Ability to maintain technical documentation and production records.
• Familiarity with 21 CFR 820 requirements in the US.

Responsibilities

• Support manufacturing processes to ensure product quality and safety.
• Maintain and update SOPs, work instructions, and production records.
• Participate in process validation activities and DOE studies.
• Collaborate with cross-functional teams including QA and regulatory.
• Assist in investigations and CAPA related to manufacturing.

Skills

Regulated industry experience

ISO 13485 knowledge

GMP principles

Process validation

DOE (Design of Experiments)

Documentation control

Education

Bachelor's degree in Engineering

Related science/technical field

Tools

Injection molding

Extrusion

Catheter manufacturing

SOPs / GMP documentation

Job description

Freudenberg Manufacturing Engineer II role in Indiana supports medical device production. The candidate will work on regulated processes, ensuring quality and compliance across molding, extrusion, catheter manufacturing, and assembly.

We seek a professional with ISO 13485 knowledge, GMP experience, and strong documentation practices to maintain robust production records and support process validation activities.