J&J MedTech is recruiting for a Staff Engineer, R&D located in Irvine, CA.

J&J MedTech (Biosense Webster, Inc.) is the global leader in the science of diagnosing and treating heart rhythm disorders. J&J MedTech established its leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter. The introduction of the company's CARTO® 3 System in 2009 revolutionized 3D mapping technology by increasing the accuracy, speed, and efficiency of the cardiac ablation procedure.

Patients with atrial fibrillation (Afib) can be at high risk for developing clot formation in the left atrial appendage (LAA) which can lead to strokes and other complications. The LAA is a small pouch in the left atrium of the heart that is a major contributor to thromboembolic stroke in patients with atrial fibrillation. In order to mitigate the stroke risk, patients with AFib undergo a surgical procedure to close the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation.

• Lead the design of new or existing components and/or devices while ensuring that all design requirements are met.
• Develop and execute test methods, procedures, work instructions, and reports with little supervision.
• Experience with design control (DFMEA, Design Input Document, Design and Development Plan, CRTM)
• Implements complex design concepts and ideas into working drawings, solid models, and prototypes.
• Study specifications, engineering blueprints, tool orders, and shop data and confers with engineering and shop personnel to resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost.
• Develop concepts, designs, and details for machines, tools and fixtures.
• Inspect and test tools and fixtures after fabrication to ensure that the meet specifications.
• Interface between external vendors and core team members.
• Prototype design and performing feasibility assessments at a rapid pace.
• Provide technical mentoring to junior engineers
• Plan, develop, coordinate, and perform engineering projects as required.
• Conduct complex or novel assignments requiring the development of new or improved techniques or procedures.
• Work hands-on to both manufacture and evaluate feasibility of prototypes.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.

• Experience with CAD software (Solidworks, Creo or similar) is required.
• Collaborative teammate with strong communication skills, written and verbal required.
• Ability to come up with creative solutions to solve technical issues
• A good understanding of concept development, 3D modeling, creating 2D drawings (good understanding of GD&T, and manufacturing methods), and rapid prototyping
• Ability to work with outside vendors for procuring parts
• Travel up to 20% may be required.

• M.S. (Mechanical, Biomedical Engineering, or equivalent) or higher education
• Able to write and communicate clearly, including generating and presenting well-written reports is preferred.
• Understanding of test method and equipment setup and validation is preferred.
• Prior experience with fixture design and tooling development is preferred.
• Prior experience with inspection of components and qualifying components for production is preferred.
• Prior experience working with injected molded parts
• Medical Device experience with 6+ years of experience
• Structural heart experience highly preferred.
• Experience with nitinol related devices
• Knowledge and experience in product development processes
• Experience with statistical analysis