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?

Quality Engineer - Product Development Medical Devices
Previous experience identifying, implementing, and adhering to quality requirements for product development projects in the medical device industry

Your tasks

  • Work collaboratively with engineers and other personnel that are assigned to the product development project team.
  • Lead the creation, documentation, maintenance, and control of Quality System Plans and Risk Management Plans with the approval of both the internal and client project teams and in accordance with applicable corporate procedures.
  • Support the creation and maintenance of risk management documentation (e.g. FMEAs, hazard analyses, risk assessments, etc.). 
  • Assist in the identification and selection of outside suppliers and consultants as required.
  • Develop, maintain, execute, and control Component Validation Plans and external supplier qualifications during the product development lifecycle.
  • Create Inspection Plans, and other component verification/validation documentation.  Facilitate the completion of component inspections and testing.
  • Initiate and lead the resolution of non-conformances / CAPAs.
  • Lead the creation and execution of test methods and test method validation plans in support of component, design, and process verification activities.
  • Analyze test data using statistical tools, perform in-depth interpretation of results, and generate detailed technical reports.
  • Provide support to project teams in the compliance of ISO13485, MDD / MDR, QSR, JPAL, and any other applicable standards or requirements.
  • Support and/or perform internal audits of the quality system and Design History Files (DHFs).
  • Create and maintain quality records for DHFs in accordance with FDA QSR and/or other regulatory requirements.
  • Support or lead design verification / validation activities including protocol and report writing.
  • Collaborate on process characterization, experimentation, optimization and qualifications.
  • Represent design assurance engineering interests in communications with clients and suppliers.
  • Incorporate the Critical Chain Project Management (CCPM) Work Norms into your daily work habits.
  • As appropriate, provide coaching and guidance regarding project tasks to other associates.

Our expectations

  • Bachelor’s degree in Engineering or related field
  • A minimum of 6 years in medical device and/or healthcare product design and product development
  • Ability to contribute in the creation of unique and innovative designs, and the processes used to manufacture them.
  • Working knowledge of Geometric Dimensioning & Tolerance (GD&T), tolerance analysis, and material properties.
  • Ability to develop and validate test methods.  SolidWorks experience a plus.
  • Understanding of various metrology, manufacturing and production monitoring techniques.
  • Ability to use analytical techniques for design verification, problem solving, and root cause analysis.
  • Working knowledge of both FDA and CE design controls
  • Experience with interacting and working with physicians and outside customers
  • Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) to management, customers and associates
  • Ability to travel as required (10%)

 

Preferred Qualifications

  • Master’s degree
  • Six sigma black belt

 

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.

We are currently hiring for a Quality Engineer – Product Development who:

  • Driven and focused on Value For Customers as defined in our Guiding Principles, ensuring that we deliver safe and effective catheter products in accordance with our Quality Policy.
  • Minimum 6 years of medical device experience, preferably in interventional devices and catheters
  • Quality System leadership experience
  • Skilled in engineering problem-solving, technical writing, and data analysis
  • Ability to effectively collaborate with and provide meaningful contribution to different roles on a project team (design, process, project planning/management)
  • Self-motivated and thrives in a fast –paced, cutting-edge environment with initiative to be proactive and seek out opportunities for improvement.

Location: 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.

Do you have any questions?

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