Manufacturing Engineer II

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

Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.

Some of your Benefits

Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.

Safe Environment: We strive to ensure safety remains a top priority, and provide a stable environment for our employees.

Corporate Events

Corporate Events: We celebrate success as a team, because only together can we achieve our goals.

Personal Development

Personal Development: We offer a variety of trainings to ensure you can develop in your career.

*Candidates must be legally authorized to work in the United States without current or future visa sponsorship*

We offer a comprehensive benefits package that includes medical, dental, and vision coverage, retirement savings with company match and paid time-off. Additional details will be shared during the recruitment process.

On-Site

You support our team as

Manufacturing Engineer II

Qualifications

• Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.
• 3+ years' experience in a regulated industry.
• Proficiency in manufacturing processes used in medical device production, such as running equipment, injection molding, extrusion, catheter manufacturing, and assembly, including the materials used.
• Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.
• Thorough understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971. Proficiency in GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements (i.e., 21 CFR 820 in the United States).
• Understanding of process validation principles and process window/repeatability studies, DOE’s, IQ/OQ/PQ, and how to validate manufacturing processes to ensure consistent product quality and necessary safety protocols.
• Familiarity with product testing and inspection methods to ensure compliance with specifications and standards.
• Ability to maintain technical documentation, including work instructions, standard operating procedures (SOPs), and production records.

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.