FM Manufacturing Engineer II

Freudenberg Medical LLC; Jeffersonville (KY); On-site; USD 80,000 - 105,000; Full time

Job summary

Freudenberg Medical LLC in the United States is seeking a Manufacturing Engineer to guide development and optimization of medical device manufacturing processes, ensuring ISO, GMP compliance and high quality.

You will lead process documentation, equipment qualification, and Lean/Six Sigma initiatives, collaborating with cross-functional teams to meet cost targets and schedule.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, or related field.
• 3+ years' experience in a regulated industry.
• Experience with medical device manufacturing processes and related materials.
• Familiarity with ISO 13485 and GMP principles and country-specific regulations.
• Knowledge of process validation, DOE, IQ/OQ/PQ, and documentation practices.

Responsibilities

• Guide development and optimization of manufacturing processes in compliance with ISO standards and GMP.
• Develop and maintain manufacturing documentation (BOMs, process flowcharts, work instructions).
• Coordinate procurement, installation, and qualification of manufacturing equipment.
• Participate in daily production meetings and collaborate with operations and customer service.
• Communicate with customers and suppliers on project matters and product quality.
• Train and support technicians and operators; lead root-cause problem solving.
• Lead Lean/Six Sigma projects to improve productivity, quality, delivery, and cost.

Skills

Problem solving

Lean Six Sigma

GMP ISO knowledge

Cross-functional collaboration

Education

Bachelor's degree in engineering/science

Job description

Working at Freudenberg: We will wow your world!

Responsibilities

• Guide the development and optimization of manufacturing processes, including tooling design and process characterization in compliance with ISO standards, country-specific and GMP regulations.
• Develop and maintain detailed manufacturing documentation, including BOMs, process flowcharts, work instructions, and test/inspection plans in compliance with quality system requirements.
• Specify and coordinate the procurement, installation, and qualification (IQ/OQ/PQ) of manufacturing equipment, fixtures, and gauges to support efficient and reliable production.
• Participate in daily production meetings (i.e., LPMS) and collaborate with operations and customer service to ensure project timelines, production goals, and cost targets are met.
• Proactively communicate with customers and suppliers on project matters, mold and fixture design/repair, validation, and product quality issues.
• Train and support technicians and operators through ongoing sustaining engineering activities.
• Analyze and solve manufacturing issues using a structured, root-cause problem-solving approach and lead cross-functional teams to implement robust, permanent solutions.
• Lead Lean/Six Sigma projects to improve productivity, quality, delivery, and cost; oversee Kaizen initiatives and eliminate waste in manufacturing processes.
• May help train new team members.

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.

Freudenberg Medical LLC Welcome to Freudenberg Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly. And these are just three examples from thousands of our applications.

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 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.