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.
You support our team as
Senior Product Development Engineer - Medical Devices
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.)
|
Freudenberg Group
June 20, 2023