Staff R&D Engineer - Catheters
5955 Pacific Center Blvd San Diego, CA 92121 | Direct Hire
Position Title: Staff R&D Engineer - Catheters
Position Description: Protingent Staffing has an exciting opportunity with our client in San Diego.
The Staff R&D Engineer will design, develop, prototype, test and debug catheter systems in accordance with established QMS policies, goals, and objectives. He/She must have the ability to make sound technical decisions, prioritize project deadlines, follow up and complete critical assigned tasks.
- Design prototypes and feasibility models for proof of concept testing
- Design and document catheter prototypes through production released products following Natus design control processes
- Perform verification of new product designs and transfer design to manufacturing
- Help prepare project plans, specifications, and schedules for new product development
- Prepare and manage Test Protocols, Reports and lab notebooks
- Identify and interact with vendors to obtain engineering materials, processes, and equipment
- Perform routine analysis of test results in relation to design specifications and test objectives
- Create and write technical product and process documents that would support Design History Files
- Other duties may be assigned.
- Bachelor’ s Degree in Engineering or technical field. Advanced degree or MBA preferred
- 3+ years’ experience of successful demonstrated experience in catheter product development and testing
- Deep Knowledge and application of following standards in the work experience -- FDA Quality System Regulations, Design Controls, Current Good Manufacturing Practices, ISO 13485, ISO 14971, Bio-compatibility testing
- Working knowledge in materials associated with catheters such as silicone, polymers (nylons, polyethylene, polypropylene, PEEK, Pebax, PTFE, FEP, polycarbonate, etc.) metals (stainless steel, aluminum, nitinol, etc.), ceramic, fiber, composites, etc. preferable
- Demonstrated strong sense of urgency and ability to manage conflicts
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.