Staff R&D Engineer

Acclarent, part of the Johnson & Johnson family of companies is currently recruiting for a Staff R&D Engineer located in Irvine, CA. 

Chronic sinusitis affects 3 million Americans each year and five per cent of the U.S. adult population suffers from a phenomenon referred to as Eustachian Tube Dysfunction (blocked ears / ear pain). Acclarent, Inc. is dedicated to supporting otolaryngologists with minimally-invasive ENT technologies that relieve this suffering as effectively and painlessly as possible. For more than a decade Acclarent, Inc. has pioneered innovative technologies, including the balloon dilation system that’s been used to treat more than one million patients.

Learn more about Acclarent at http://acclarent.com/ and follow us on LinkedIn .

The Staff Engineer develops concepts, designs, and details for products, machines, tools, fixtures, and test methods.  This position will have responsibilities across the needs of the cross functional groups of the Acclarent organization.

Key Duties:

• Designs new devices based upon customer need
• Test designed prototypes and modifies design based upon test results
• Documents designs for characterization, pre-V&V and V&V activities
• Plans, coordinates and oversees validation operations, including scale up of and optimization processes, equipment assembly, in process sample analysis, and prepares compliance documents
• Proposes and determines new or improved technologies to enhance product quality, manufacturing cost efficiencies, personnel safety and regulatory compliance
• Evaluates analytical results to establish the quality of tests and batches
• Prepares and controls procedure, batch records and other compliance documents
• Oversees timely completion of pilot plant operations consistent with new product production activities of the department
• Manages the transfer of manufacturing technologies from concept to pilot to full production
• Prepares and assists in the execution of the manufacture of process validation batches, and prepares the process validation report
• Motivates and mentors’ others
• Ensures equipment is tested and supports safety and environmental initiatives
• Ensures repairs are scheduled
• Creates IP and works with patent attorneys to ensure patents are applied for
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for ensuring team members follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Performs other duties assigned as needed