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. Come join our GROWING team! 

 

Ready to make a difference?

Advanced Manufacturing Engineer II - New Product Introductions
Advanced Manufacturing Engineering & Equipment Design group (AME) are creating innovative new processes for New Product Introductions to drive customer satisfaction with life saving medical devices

Your tasks

  • Develop manufacturing processes. Utilize cross-functional participation to ensure that the equipment and process and processes are compatible with the entire value stream. Efforts should include: Early equipment management (TPM), workstation design, material presentation, standard work and single piece flow.
  • Working with PD team, ensure design/process capability has been successfully completed before launch.
  • Define and implement equipment set needed to support Pilot & Full-Scale Production
  • Define and control production process including tooling and equipment. Validate design specifications and shop floor application of new product, tools, or equipment.
  • Prototype equipment designs quickly with a combination of in-house machining and contract manufacturers
  • Drives effort of identifying and implementing affordable error proofing and automation technologies.
  • Ensure the implementation of project schedules
  • Working closely with Operations team to ensure all facilities are prepared for new product launches
  • Supports the development and use of all production and control related processes and documentation including APQP, Control Plans, Qualification Plans, Engineering Change, Deviations, Corrective and Preventative Actions, DFMEA, PFMEA, PPAP, FAI, DFMA, and SPC tools
  • Identify and establish new processes and technologies necessary to achieve best cost targets
  • Provide coaching, and guidance regarding project tasks to other engineers, designers, technicians and associates.

Our expectations

  • Bachelor’s Degree required, Master’s Degree in Mechanical/Electrical/Bio-Medical Engineering preferred
  • 3+ years of experience working as an engineer in a complex assembly manufacturing environment with experience for New Product Introduction.
  • Experience and demonstrated success in implementing capital projects
  • Ability to develop a technical strategy and roadmap, develop and implement the tactical steps to drive the team to achieve the strategy
  • Must have experience in a structured regulatory environment with advanced quality systems such as ISO13485, ISO 9001, AS9100, TS16949 or equivalent. 
  • Experience in designing, procuring, assembling, troubleshooting and validating equipment
  • Detail oriented with excellent project management skills
  • Track record of working in fast paced environments
  • Ability to work on many different projects at the same time
  • Strong interpersonal, oral and written communication skills with the ability to effectively communicate with all levels of the organization, customers and suppliers

 

Preferred Qualifications:

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

 

Freudenberg Medical, part of the Freudenberg Group, is a global partner for the design, development and manufacture of innovative medical devices and components. With 11 manufacturing operations and more than 1,500 associates worldwide, Freudenberg Medical offers a wide range of manufacturing capabilities from high precision molding and extrusion to drug coatings, finished devices, and subassemblies for catheters and minimally invasive devices.

For over 30 years, medical device and healthcare companies have trust Freudenberg Medical to manufacture their custom components and devices. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Design and manufacturing operations are located in the United States (California, Indiana, Massachusetts, Minnesota), Germany, Ireland, Costa Rica, and China.

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: Louisville, KY (Facility in Jeffersonville, IN)

 

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. #LI-FM2020

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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