Product Development Engineer II

Freudenberg Medical

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.

 

Your tasks

Work collaboratively with other engineers and personnel from client companies assigned to a development project

Participate in brainstorming sessions to identify creative ideas and unique solutions

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.

Participates as a member of a Product Development project team.  The role of the PDE is to contribute to the technical aspects of project including product design, verification, and validation.

Be responsible for meeting overall project deliverables and objectives.

 

Our expectations

Bachelor of Science engineering degree, BSME or BSBME (or related discipline) and experience, in the medical device field.

3 - 5 years’ experience in product development for a manufacturing company in medical device industry

Extensive experience with Solidworks is required

Technical product development experience, e.g. design, process, or quality engineering

Working knowledge of both FDA and CE design controls

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 catheters, extrusion and electrophysiology (EP) systems

 

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.

We currently have 300+ employees and are currently hiring for a Product Development Engineer II who is:

Catheter Development experience

SolidWorks design and drawing

Hands on prototyping

Must be a self-starter who is willing to learn and take direction, and work well in cross functional teams.

Location: Minnetonka, MN 55305

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.

More Information / Apply Now

Type

Junior industry position

North%20America%2C%20Minnetonka%2C%20United%20States

North America

Minnetonka , United States

Location

United States

Minnetonka

Type

Junior industry position

North%20America%2C%20Minnetonka%2C%20United%20States