The Catheter/Balloon Development Engineer plays a prominent role in the development of vascular access devices from conception, prototyping, design and development of catheter-based devices and their processes using design and development systems in accordance with FDA and international regulations.The position supports the manufacturing line for New Product Introductions (NPI) as well as improvements, modifications, and further deployment of sustaining production lines of Catheter products. The position participates in product development teams that specify, build, test, and challenge new product designs to improve efficacy, reliability, serviceability, manufacturability, and cost. This position requires high technical competence along with being a team player, self-starter, and possessing a can-do attitude.
- Strong knowledge of manufacturing processes related to catheter design and manufacturing such as extrusion, braiding, coiling, reflow and tipping.
- Knowledge of manufacturing processes related to both compliant and non-compliant balloons.
- Hands on capability to fabricate proof-of-concept catheters utilizing standard catheter fabrication equipment.
- Knowledge of commonly used materials for liners, extrusions, marker bands, braid and coil wire materials and tempers.
- Knowledge of materials commonly used for occlusion and dilation balloons.
- Knowledge of transitioning from prototyping / proof-of-concept to sustainable, repeatable manufacturing processes.
- Ability to translate functional catheter requirements of trackability, pushability and torqueability into materials and construction.
- Ability to design and fabrication test fixtures to verify catheter functional requirements.
- Leads or plays a prominent role supporting product development projects capturing and documenting design inputs and outputs from feasibility through design transfer into manufacturing.
- Authors and executes product and system specifications, validation and test protocols and validation and test reports.
- Assesses reliability, safety, performance and risk of new designs and methodologies and insures individual and group safety when conducting all activities.
- Supports manufacturing activities, as necessary.
- Design, document, assemble, qualify, and introduces production assembly/test/inspection fixtures and equipment. Designs and creates production equipment, fixtures and tests as needed to build the production line either internally or as needed at suppliers.
- Provides product and process DFM (Design for Manufacturing) input to Product Development Engineering team to enhance manufacturability and product cost. Creates an efficient manufacturing assembly line, specifying and/or refining BOMs, workflow processes and detailed work instructions.
- Must possess strong communication skills to interface with operators, technicians, product development, planning, purchasing, regulatory, inspection, clinical marketing organizations, and suppliers. Mentors and sets project tasks for Engineers on their specific project team and on other teams as needed to further company expertise & effectiveness.
- Leads/participates in continuous improvement initiatives focused on material cost reduction, capacity enhancement, and streamlining of supply chain.
- Works jointly with Manufacturing Product Engineering, Manufacturing, Quality Control, and Quality Engineering to assure assigned processes successfully produce affected components or subassemblies according to applicable drawings, specs, and/or procedures.
- Travel to vendors, trade shows and between facilities, possibly overseas
- A strong understanding of product and process development of medical devices.
- The ability to work independently and in a team setting with demonstrated experience working cross-functionally and leading teams to accomplish goals.
- The ability to manage complexity in a fast-paced environment.
- An advanced understanding of the entire development process, including specification, documentation and Quality Assurance.
EDUCATION AND EXPERIENCE REQUIREMENTS:
- A bachelor’s degree in Engineering and 4-8 years of experience specifically designing and developing vascular catheters in a medical device development environment OR an equivalent combination of education and experience is required.
- Demonstrated understanding of manufacturing processes including injection molding, machining, lamination, braiding and process capabilities. Demonstrated knowledge of mechanical assembly, testing, and inspection processes and Lean principles.
- Solid modeling/CAD experience (SolidWorks preferred).
- Strong problem solving ability, including demonstrated ability to effectively design, execute, report on, and draw conclusions from experiments.
- Excellent communication, organization, follow-up, and documentation skills. Comfortable interacting with technicians, engineers, and management all on a regular basis.
- ISO 13485, 21 CFR Part 820, or experience in medical device manufacturing environment.
- Ability to successfully perform job duties in a fast pace, quick changing entrepreneurial environment.