Mehrdad "Mike" Shokoohi                                                                           

Project Manager/ Sr. Consultant

Mike has fourteen years of experience in development and manufacturing of medical devices and systems.   Result-focused professional with proven ability to create and develop strategic solutions to resolve complex design, process and system issues.   He possesses excellent organizational and leadership skills.           

EXPERIENCE...

• Managed cross-functional teams to launch new and innovative products.
• Hands on experience from design development stage through manufacturing and market release.
• Assessed strategic competitive environment, through analytical and diversified technical abilities.
• Managed device/system testing and characterization to support regulatory registration.  
• Expertise in design and development of prototype devices and experimental models.  
• Experienced in quality management system s, GMP, ISO 9001, EN 46001, MDD and AAMI standards.   
• Managed device biocompatibility, reliability, and performance evaluations by external contractors.
• Launched three platform products from the R&D prototype stage to full-scale manufacturing for Cardiovascular Dynamics (CVD)
• Transferred multi-million dollar a year angioplasty products and developed and executed design of experiment studies to validate process and improve device performance
• Principle designer of a vascular prosthesis for treatment of abdominal aortic aneurysms percutaneously.
• Interfaced with physicians to evaluate clinical performance of medical devices and experimental models.
• Developed and structured the Engineering, Manufacturing, and the support departments for a medical device company.
• Initiated design enhancements in compliance with GMP and ISO 9001 standards.
• Implemented the JIT manufacturing and information mapping procedures.
• Established on line product reliability testing and process capability program.
• Performed product and process validations including process capability analysis.
• Conducted device/system sterilization validation on steam, ETO, and E-beam sterilization methods.     
• Re-Engineered processes to eliminate non-value-added operation
• Investigated field complaints and formulated corrective actions on manufacturing problems.
• Performed design/process enhancement studies to improve product safety/efficacy.
• Performed process/inspection capability analysis to establish process limits.
• Responsible for Polymer extrusion operation and catheter development of critical care products.
• Developed product quality inspection methods, procedures, tools, and fixtures.
• Qualified new products including tools, fixtures and processes.
• Implemented a View Bazic 8, an automated non-contact inspection system for tubing extrusion line.

                                                                                                                                                                                                                                                POSITIONS HELD...

• Sr. Quality Engineer                                              BioTeknica
• Director of Operations                                          Artisan Inc.
• Development Manager Pilot Operation                 Alcon Research LTD
• Director of Research & Development                  Endologix Inc.
• Manufacturing Engineering Manager                   Cardiovascular Dynamics Inc.
• Sr. Manufacturing Engineer                                  Advanced Cardiovascular Systems (Guidant)
• Quality Assurance Engineer                                 Advanced Cardiovascular Systems (Guidant)
• Quality Assurance Engineer                                 Baxter Edwards Critical-Care Division

EDUCATION...

• B.S. in Mfg. Engineering & Technology   California State University

PATENTS...

• Bifurcated Endoluminal Prosthesis: WO 9965419 US pendingEndoluminal Vascular Prosthesis: WO 9944536 US 6077296
• Multilumen Delivery System Catheter: Pending