Manufacturing Engineer II

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

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

• 401K Match: Save for retirement with the company's help.
• 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: We celebrate success as a team, because only together can we achieve our goals.
• 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.

Jeffersonville, IN

On-Site

Freudenberg Medical LLC

Manufacturing Engineer II

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.