Manufacturing Engineer II
Freudenberg · Jeffersonville, IN
- Level
- Engineer
- Team
- Manufacturing
- Degree
- Required
- Experience asked
- 3+ years
- Industry
- Industrial
- Posted
- 30+ days ago
The role in 30 seconds
An engineer-level manufacturing role at Freudenberg (industrial) in Jeffersonville, IN. Guide the development and optimization of manufacturing processes, including tooling design and process characterization in compliance with ISO standards, country-specific and GMP regulations.
- They ask for
- 3+ years · degree required
- Tools it names
- Lean, Six Sigma, Kaizen, Root cause, DOE, ISO 13485
Read from the posting. The full description is below.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Manufacturing team at Freudenberg
Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
- 3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Is the work mostly new product launches or sustaining existing lines?
- How much time do you spend on the floor versus at a desk?
- How did you land the job? What stood out in your interviews?
- 4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
About the role
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.
Freudenberg Medical LLC
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