The Freudenberg Group, a global technology group with 48,000 employees in some 60 countries, develops leading-edge technologies, and excellent products, solutions and services for more than 30 market segments. Freudenberg & Co. Kommanditgesellschaft, with its Headquarter in Weinheim, is the strategic parent company of the broadly diversified Group. Freudenberg Medical is a leading global manufacturer of components for medical devices, complex catheter systems for minimally-invasive surgery and total solutions for the biotech, healthcare and pharmaceutical industries.

Senior Manufacturing Engineer

Your tasks

  • Ensure the production line receives top priority in order to meet or exceed customer expectations.  Attend  daily meetings on the line with the Cell Team., to review the previous days production, any issues, and projected activities
  • Review the visual production board several times daily for issues related to productivity, downtime, equipment issues, defects and develop improvement action plans
  • Provide associates clear manufacturing instructions and standards of work to drive improvements in the quality of the products.  Ensure actual associate work is reflected in manufacturing documentation and trained properly.
  • Ensure equipment and line is validated, qualified, and calibrated.  Support Maintenance to ensure that the equipment is maintained in a manner that maximizes equipment life and performance and minimizes impact to production.
  • Support and/or lead activities for identification of root causes of non-conformances. If a CAPA is issued support the efforts to ensure the item is closed in an appropriate amount of time.
  • Create and maintain quality system documentation such as process failure mode effects analysis, process flow charts, process validation plans, validation protocols, manufacturing procedures, etc.
  • Provides engineering support for successful product launching to production and resolve issues as they arise.
  • Develop expertise in specialized catheter manufacturing processes, which includes but is not limited to braiding, coiling, heat transfer, etc.
  • Analyze test data using statistical tools, perform in-depth interpretation of results, and generate detailed technical reports
  • Support maintenance and/or tooling to ensure the equipment is maintained in a manner that maximizes equipment life and performance
  • Collaborate with the Production Manager to identify and improve key performance indicators of product processes such as yield improvements, cycle time reductions, material cost per unit reductions, labor cost per unit reduction, etc.
  • Work collaboratively with clients, Production Managers, and other engineers for new and sustaining product
  • Provide coaching, and guidance regarding project tasks to other engineers, designers, technicians and associates.

Our expectations

  • Bachelor of Science preferably Industrial, Manufacturing or Mechanical Engineering.
  • 6+ years of experience working as an engineer in a manufacturing environment in the medical device industry.
  • Previous supervisory/leadership experience.
  • Must have experience in a structured regulatory environment with advanced quality systems such as ISO13485, ISO 9001, AS9100, TS16949 or equivalent. 
  • Must demonstrate ability to work independently and with others in a fast-paced, results oriented environment
  • Familiarity with statistical problem solving and six sigma techniques to make educated decisions based on data.
  • Attention to detail and able to work independently and on a team with little supervision
  • Strong interpersonal, oral and written communication skills with the ability to effectively communicate with all levels of the organization, customers and suppliers
  • Mechanical aptitude

Preferred Qualifications:

  • Green Belt certification in Lean or Six Sigma.
  • Working knowledge of SolidWorks and AutoCAD software, 2D& 3D.

Freudenberg Medical is a global partner for the design, development, and manufacture of innovative medical device technologies.  We offer the following services medical device, pharmaceutical and IVD clients worldwide − product design and development, silicone and thermoplastic molding and extrusion, complex catheter systems, assembly, packaging, and engineering services.

For nearly 30 years, medical device and healthcare companies around the world have looked to Freudenberg Medical to make a difference as the custom manufacturer medical industry leaders can trust. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Freudenberg Medical maintains design and manufacturing centers in California, Indiana, Massachusetts, Minnesota, Costa Rica, Europe and Asia. 

Freudenberg Medical manufactures minimally invasive, handheld and catheter-based devices out of our 93,000 square foot state-of-the-art facility, strategically and centrally located in Jeffersonville, Indiana. Freudenberg Medical’s culture is positive and team oriented. In our environment we like to have fun while helping others with our cutting edge medical devices. Our company is very driven to lead in the medical device industry to improve the quality of life of the patients we serve.

Freudenberg Medical is a local, innovative, high growth company with a collaborative, high performance work environment. We develop and manufacture minimally invasive, single use medical devices in the endoscopy, cardiovascular, neurovascular, and urology markets. The products we develop and manufacture are typically market disruptive and displace higher cost procedures.

Location: Jeffersonville, IN 47130

We are currently hiring for a Senior Manufacturing Engineer who:

  • Enjoys providing engineering support on the production floor as well as participate in the design transfer and scale up of complex assembled catheter products and medical devices
  • Understands launching new medical device projects and can work with operators to exceed our customer expectations
  • Is focused to lead continuous improvement efforts to increase productivity through lean principles
  • Must be a self-starter who is willing to learn and take direction, and work well in cross functional teams.

It’s an exciting time to work at Freudenberg Medical. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make Freudenberg Medical the employer of choice in this industry. We offer a competitive salary plus a full range of benefits including medical, dental and vision insurance, as well as 401K Match.

Do you have any questions?

Freudenberg Medical Minimally Invasive Solutions
Rachel Peterson ∙ Human Resources ∙ 2301 Centennial Blvd. ∙ 47130 Jeffersonville, IN ∙ www.freudenbergmedical.com/MIS
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