Working in a dynamic team environment, the selected candidate will contribute in many phases of new catheter product development including, detailed engineering and testing, process development and characterization and design for manufacturing.
The Sr. New Product Introduction Technician will work both independently and with other members of the product and process development team to prototype, develop, characterize, test and debug novel catheter systems in accordance with established policies, goals, and objectives. The ability to make sound technical decisions, prioritize tasks, follow up and complete critical items is essential. This individual will be required to quickly generate numerous prototypes from verbal and written instruction, using experience to select best approach and contribute to design improvements
- Prototype, debug, test and refine novel ideas, device concepts, and technologies
- Work with catheter team to brainstorm and prototype improved designs for ease of manufacturing with minimal supervision and guidance
- Develop and improve manufacturing processes to pilot production level
- Support efforts to verify and validate new product and process designs
- Prepare and execute test protocols, and maintain lab notebooks
- Complete dimensional and functional testing and complete test reports and perform preliminary data analysis
- Identify and interact with vendors to obtain engineering materials, processes and equipment
- Perform basic analysis of test results in relation to design specifications and test objectives
- Assist engineering team in maintaining adequate inventory of engineering and prototype materials
- Work in machine shop to design, build, modify, and/or prototype fixtures and components
- Complete detailed work instructions and train manufacturing operators
- Participate in design control activities such as SolidWorks Drawings and DCN documentation
- 5 years experience as an engineering technician in the medical device industry, specifically catheter development.
- Associate’s degree in Engineering or Science a plus.
- Must have a demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams. Both written and oral skills required.
- Must be a self-starter, well organized, and take direction from multiple people.
- Must have strong hands-on prototyping skills, experience with rapid prototyping, experience at measuring and testing, as well as a good background in the catheter manufacturing processes.
- Must have significant experience with SolidWorks, CAM, CNC, general machine shop tools and equipment, and Microsoft Word and Excel.
- Extensive knowledge and proven track record of catheter design, as demonstrated by being a successful member of team taking product from concept to production.
- Excellent time management skills, comfortable working on multiple projects at once.
- Experience working with ISO requirements, GMP guidelines, FDA regulations, medical device design control, and manufacturing scale-up processes.
- Previous start-up experience a plus.
Hansen Medical, Inc. is an Equal Opportunity Employer.