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?

Senior Product Development Engineer - Interventional Medical Devices

Your tasks

  • Work collaboratively with other engineers and personnel from client companies assigned to a development project
  • Conduct &/or participate in brainstorming sessions to identify creative ideas and unique solutions
  • Contribute to the technical aspects of project including product design, verification, and validation.
  • Translate user needs and other customer input into clear, concise design requirements and design concepts.
  • Create and document design concepts through the use of 3D CAD software and rapid prototyping methodologies
  • Create concept models and prototypes utilizing small tools and equipment.
  • Create specifications for device components, assemblies, packaging, and labeling
  • Work with Manufacturing and other Product Development engineers to ensure that products are optimally designed for manufacturing.
  • Assist in the identification and selection of outside suppliers and consultants as required.
  • Prepare for and conduct various design reviews in accordance with regulatory requirements
  • Verify that designs meet functional requirements through the performance of engineering analyses and testing.
  • Assist in the development of test and inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.
  • Prepare for and facilitate risk assessments throughout the product development lifecycle.
  • 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.
  • Specify fixtures, gauges, and equipment needed for the verification and manufacture of small quantities of prototype devices
  • Work with clients and client patent counsel to prepare invention records and assist in the patent submission process.
  • Provide technical support to manufacturing engineering for design and process improvements made post transfer to sustaining manufacturing.
  • 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 engineering degree, BSME or BSBME (or related discipline) and experience, in the medical device field.
  • 7 + years’ experience in product development for a manufacturing company in medical device industry
  • 5 years’ experience with catheters and catheter-based systems
  • Knowledge of catheter molding design and assembly processes (extrusion, braiding, coiling, reflow, etc.)
  • Technical product development experience, e.g. design, process, or quality engineering
  • Working knowledge of both FDA and CE design controls
  • Extensive experience with Solidworks is required
  • Strong technical writing ability.
  • Leadership ability and organizational skills.
  • Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work.
  • Proficiency in the use of PC and programs, particularly Project, Excel, Word, PowerPoint.
  • Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) both to senior management, customers and associates
  • Execute tasks in a timely manner without direct supervision.
  • Ability to prioritize tasks.
     

Preferred Qualifications

  • Mechanical Design Degree
  • Previous experience with interventional medical products: catheter based technologies (cardiovascular, neurovascular, peripheral vascular, etc.)

 

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: Jeffersonville, IN)

We are looking for a Senior Product Development Engineer who is:

  • Driven and focused to provide engineering expertise in support of design and development activities for new and / or existing minimally invasive medical technologies.
  • Determined to develop concepts and test prototypes including design specifications and initial processes to properly make and assemble new medical products.
  • Leadership driven to help mentor junior engineers.
  • 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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