Careers that make a difference! Freudenberg Medical designs and manufactures medical devices and components for clients worldwide.  We are focused on innovative processing technologies, lean manufacturing, waste reduction, and high quality product solutions for our Fortune 100 medical device customers.  Join our fast growing team with 11 manufacturing operations around the world. 

 

Ready to make a difference?

Sr Catheter Process Development Engineer
Previous design and/or process development experience in medical catheter-based and balloon technologies.

Your tasks

  • Develop expertise in specialized catheter manufacturing processes, which includes but is not limited to braiding, coiling, heat transfer, etc.
  • Work collaboratively with other engineers and personnel from client companies assigned to a development project to ensure that products are optimally designed for lean manufacturing.
  • Conduct &/or participate in brainstorming sessions to identify creative ideas and unique solutions.
  • Create concept models and prototypes utilizing small tools and equipment.
  • Specify fixtures, gauges, and equipment needed for the verification and manufacture of small quantities of prototype devices.
  • Assist in the identification and selection of outside suppliers and consultants as required.
  • Be responsible for meeting overall project deliverables and objectives, as assigned.
  • Create and maintain quality system documentation such as process failure mode effects analysis, process flow charts, process validation plans, validation protocols, manufacturing procedures, etc.
  • Prepare for and conduct various design reviews in accordance with regulatory requirements.
  • Assist in the development of test and inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.
  • Utilize common laboratory test equipment to perform hands-on mechanical and electrical testing.
  • Analyze test data using statistical tools, perform in-depth interpretation of results, and generate detailed technical reports.
  • 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.
  • Provides engineering support for successful product launching to production and resolve issues as they arise.
  • Support maintenance and/or tooling to ensure the equipment is maintained in a manner that maximizes equipment life and performance.
  • Collaborate with the PD Team 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.
  • In a non-supervisory capacity, provide coaching and guidance regarding project tasks to other engineers, designers, technicians and associates.
  • Promote employee development and foster growth of employees through effective mentoring.

Our expectations

  • Bachelor of Science technical degree in Industrial, Manufacturing, or Mechanical Engineering
  • Mechanical aptitude
  • Familiarity with statistical problem solving and six sigma techniques to make educated decisions based on data.
  • Previous experience with catheters, extrusion, balloons, and electrophysiology (EP) systems
  • 6 - 10 years’ experience in product/process development and/or manufacturing environment for a medical device manufacturing company
  • Technical product development experience, e.g. design, process, or quality engineering
  • Working knowledge of both FDA and CE design controls; experience in a structured regulatory environment with advanced quality systems such as ISO13485, ISO 9001, AS9100, TS16949 or equivalent.
  • Attention to detail and able to work independently and on a team with little supervision; ability to prioritize & execute tasks in a timely manner without direct supervision.
  • Leadership ability and organizational skills.
  • Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work.
  • Strong technical writing ability and ability to communicate ideas and information clearly, effectively, and frequently (oral and written) both to senior management, customers and associates.  Proficiency in the use of PC and programs, particularly Project, Excel, Word, PowerPoint.

 

Preferred Qualifications

  • White or Green Belt certification in Lean or Six Sigma
  • Working knowledge of SolidWorks software

 

 

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: Minnetonka, MN 55305

We are looking for a Senior or Principal Catheter Process Development Engineer who is:

  • Driven and focused to provide engineering expertise in support of process and manufacturing development activities for new and / or existing medical catheter-based and balloon technologies.
  • Determined to develop and test catheter & balloon prototypes, including development of initial processes to properly make and assemble new medical catheter-based products.
  • Understands launching new medical device projects and can work with manufacturing operators to exceed our customer expectations.
  • Is focused to lead continuous improvement efforts to increase productivity through lean principles.
  • A team player focused on the success of the group along with a desire to continuously learn and develop.
  • Self-motivated and thrives in a fast –paced, cutting-edge environment with initiative to be proactive and seek out opportunities for improvement.

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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