Robert B. Email & Phone Number

San Clemente

Responsibilities: lead engineer design/development/transfer/design controls/team leadership of MIGS stent delivery device, iStent Inject/iStent Supra, class 7 cleanroom product/process design, and manage plastic vendor base. Redesign of IDE surgical device for improved functionality, reduced part count, ergonomic design and manufacturability. Conducted voice of customer (design I/O, verification) and in-house wetlab evaluations with surgeons. Mentor junior engineers on good design practices along with Solidworks/good drawing practices (GD&T). • Successfully launched flag ship product (iStent Inject) from PMA design through market release. Projected gross sale of $150 million per year.• Technical design lead for (iStent Supra) PMA program. Projected gross sales of $20 million per year.• Design and develop point of sale packaging for sterility, ease of use, and product preservation.• Responsible for the Design History File, Design Reviews, data generation for FDA (PMA) submissions, and all related documents.• SME Plastics Design/Material Selection

Lake Forest, Ca

Responsibilities: Helped design and development of new cataract disposable cassette used in a proprietary Centurion console. Lead team that developed hermetic ultrasonic sealing of high volume plastic cassette. Work with R&D on continuous improvements and future generation devices.• Developed and implemented plastic mold tooling for in house-manufacturing of a very high volume, single use commercial cataract surgical cassette.• Developed cassette clogging protocol which involved aspirating porcine lens in substitute for human lens through small diameter tubing including all test procedures and protocols. Design team member on Centurion Vision Systems consumables, which included high volume plastic welding along with transfer over to manufacturing. • Verification and validation protocols which include FMEA, IQ, OQ, PQ, and Design of Experiments protocols leading to 510K submission.

Camarillo, Ca

Responsibilities: Design of mechanical systems and subsystems for new type of fuel injector. Designed piston pumps, test fixtures, along with ancillary engine components and their machining processes for manufacture on internal shop equipment. Coordinated and directed all internal machine shop flow.

Rancho Santa Margarita

Managed new tooling programs for high quality, high volume medical products. Evaluated and specified repairs to existing plastics injection mold tooling. Lead design engineer for disposable grasper project including development of test protocols and the DHF, maintaining project schedule through design cycle. Designed silicone occlusion catheter short-term implantable balloon program from concept to market release. Compiled Design History File in compliance to FDA’s Design Controls and CE/510 K requirements.

Simi Valley

Designed new products for inkjet, laser, and ribbon printer supplies. Contributed to continuous product improvement of various printer products. Design team member for new ribbon printer cartridge, taking program from inception through production release. Managed and coordinated all existing tooling maintenance

Northridge, Ca

Developed, and designed plastic components including materials selection for speaker enclosures and consumer electronic components. Assisted molding vendors in troubleshooting process parameters to obtain best quality parts. Specified tooling, and followed tool build cycle through production verification. Sourced vendor base for plastic materials, molded parts, and tooling for global Harman divisions.

Greater Detroit Area

Managed fascia injection molding programs from design inception to production. Coordinated and designed related injection molding parts, tooling and fixturing. Designed plastic parts to replace traditional steel parts. Assisted in the advanced process molding studies for multilayer injection molding of fascias

Master Of Science - Ms, Plastic Engineering, 3.92

Master of Science Plastic Engineering

Bachelor Of Science - Bs, Industrial Engineering, 2.5