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Senior Product Development Engineer - Medical Devices

Company: Freudenberg Medical LLC
Location: Minnetonka
Posted on: September 23, 2022

Job Description:

Freudenberg is a global technology group that strengthens its customers and society long-term through forward-looking innovations. Together with our partners, customers and the world of science, we develop leading-edge technologies, and excellent products, solutions and services for 40 market segments. The Freudenberg Group employs some 50,000 people in around 60 countries worldwide and generates sales of nearly 9 billion euros. At Freudenberg Medical, we make products that save and improve the lives of people every day, all around the world. We are a global provider for medical device design and manufacturing with 11 locations worldwide and more than 1,800 employees. Innovation is at the core of our company and we are proud of our industry-leading quality, lean manufacturing, and focus on innovation in products and processing technologies. Freudenberg Medical is an exciting place to work with lots of opportunity to learn, develop, and grow your career. Come join us and together we can make a difference in the future of healthcare.
Responsibilities
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.
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.
Qualifications
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.)
Your Benefits
Performance-related bonus: When you have an impact, you can reap the rewards
Diversity & Inclusion: Enter a diversity-driven world of innovation
401K Match: Save for retirement with the company's help
Company events: Events to built teams and relationships prime for accomplishment
Training / Career development: Programs to supercharge skills and expertise
Additional Information
Rachel Peterson
Discover more about us

Keywords: Freudenberg Medical LLC, Minnetonka , Senior Product Development Engineer - Medical Devices, Engineering , Minnetonka, Minnesota

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