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.

Sr Design Engineer - R&D Catheter Medical Devices
Previous experience in designing new medical devices focused on minimally invasive complex catheters.

Your tasks

  • Apply engineering knowledge to the design and development of new products and product changes and enhancements to existing products.
  • Perform functions to establish feasibility of concepts and determine specific design inputs and requirements for new products.
  • Perform risk analysis and reliability activities for new and existing products.
  • Responsible for Technical Device Reviews
  • Design new and existing products including, but not limited to, solid modeling (SolidWorks preferred), specifications and tolerances.
  • Lead the development of product test methods, incoming inspection requirements and product packaging and labeling.
  • Perform design verification and validation to include protocol development, builds, testing, and reports.
  • Maintain current knowledge of competitive technologies in the medical device industry.
  • Support the development of manufacturing processes and procedures
  • Write invention disclosure to support patent applications.
  • Communicate design related issues with internal and external team members
  • Provide proper documentation for design tasks to support FDA Quality System requirements, other regulatory bodies and customer requirements. (e.g. lab notebooks or technical memos)
  • Develop and manage the Design FMEA and Hazard Analysis, design traceability matrix (DTM) along with formal and informal protocols and reports and document Inventions.
  • Assign work to technicians, peers and temporary employees as needed along with oversee and assist in the selection of outside vendors and consultants as required.
  • Provide leadership and direction on project teams as it relates to the design engineering deliverables.
  • Manage schedule while providing technical leadership.

Our expectations

  • Bachelor of Science degree in Mechanical Engineering (or related disciple) and experience, in the medical device field.
  • 10 + years’ experience in all job requirements within the medical device industry
  • Extensive experience with Solidworks is required
  • Strong technical writing ability.
  • Experience with Catheters and Electrophysiology (EP) Systems
  • Experience with ISO 10993 biocompatibility testing.
  • Familiarity with rapid prototyping techniques.
  • Experience with fabrication of proof of concept models.
  • Ability to identify and create unique and innovative designs.
  • Ability to formalize concepts for production fabrication of parts and assemblies.
  • Ability to create detail drawings for production fabrication of parts and assemblies.
  • Working knowledge of Geometric Dimensioning & Tolerance (GD&T), knowledge of materials and the characteristics of parts when fabricated from different materials (e.g. polymers and metals).
  • Knowledge of tooling and process to produce component parts.
  • Understanding of various manufacturing and production monitoring techniques.
  • Ability to use analytical techniques for design verification, problem and root cause analysis.
  • Working knowledge of both FDA and CE design controls
  • Ability to build and manage project schedules
  • Run project meetings
  • Experience with interacting and working with physicians and outside customers

 

Preferred Qualifications

  • MBA degree or the educational equivalent

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 (near Louisville, KY)

We are looking for a Senior Design Engineer – R&D Catheter Medical Devices who is:

  • Resourceful and driven, focused on innovative solutions in catheter medical devices in a collaborative environment.
  • An energetic and dependable leader who enjoys developing innovative medical device products and fostering accountable teams.
  • 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.

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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