Engineering Medical

Mehrdad Mike Shokoohi

**** *. ********** ***. #***

West Palm Beach Florida 33407

**********@***.***

Phone:305-***-****

Summary

Senior Product Development and Operations Executive seeking a career position with a growing lifesciences organization. Result-focused professional with proven ability to create and develop strategic solutions to resolve complex design, process and system challenges. An effective change agent with excellent organizational and leadership skills. An analytical problem solver with attention to details.

Selected Accomplishments

Participated in two successful private venture start-up companies and initial public offerings.

Managed cross-functional teams to launch approximately a billion dollars’ worth of innovative products.

Supported FDA regulatory remediation process and market clearances for several top fortune 100 companies.

Professional Profile

Hands on experience from design development stages, to manufacturing, and commercialization.

Assess strategic competitive environment, through analytical and diverse technical abilities.

Lead cross-functional teams to achieve organizational objectives through diligence and collaboration.

Manage device/system testing and characterizations to support regulatory submissions and registrations.

Experience in design and development of prototype devices and experimental models.

Conduct process capability analysis, design of experiments (DOE) for six sigma operations.

Manage device biocompatibility, reliability, toxicity, sterilization evaluations per GLP standards.

Lead capital projects, cleanroom development, expansion, and commissioning of manufacturing equipment.

Experience in design control, product/process performance optimization and validations, CAPA.

Experience in Quality Management Systems lean six sigma, ISO 13485, 21 CFR part 11, 21 CFR 820, cGMP, and ISO 9001, risk management ISO 14971, EN 46001, MDD, ASTM and AAMI standards.

Professional History

Telesis Research LLC, Miami, Florida 04/2017 to 10/2019

A Lifesciences engineering firm specialized in development and manufacturing of Medical Devices.

Director of Operations.

Optimized manufacturing processes for Lean operational performance and maximum productivity.

Implemented lean and six sigma manufacturing operations for optimum process performance.

Developed product process manufacturing specifications and quality standards throughout the supply chain.

Resolved design, manufacturing, and quality issues to improve product quality and reliability per cGMP.

PharmaBioServ, Los Angeles, California 07/2016 to 03/2017

A publicly traded consulting firm specialized in Regulatory, Compliance, Quality, Engineering projects catering to medical devices, pharmaceutical, and life science industries.

Director of Operations, US South Region

Supported development of business, and engineering project plans for technical resources at client’s sites.

Analyzed and updated quality management systems QMS, procedures for multi-national clients.

Developed and executed statement of work, contracts, and prioritized project deliverable activities.

Reviewed and approved validation protocols, and final technical reports as subject matter expert.

Mehrdad Mike Shokoohi

2191 N. Australian Ave. #605

West Palm Beach Florida 33407

**********@***.***

Phone: 305-***-****

Telesis Research LLC. Coral Gables, Florida 11/2010 to 06/2015

A private capital venture engaged in development and manufacturing of implantable bioabsorbable, drug eluting medical devices for treatment of vascular disease through percutaneous implantations.

Director of Engineering- Research & Development, Chief Technology Officer/Cofounder

Coordinated cross functional teams to develop several design concepts for implantable drug eluting self-expanding bioabsorbable vascular prosthesis.

Developed company’s core technology and working with IP counsel were able to ascertain three US patents.

Led the due diligence processes to identify and develop gold standard supply chain for all components.

Completed device in-vitro, in-vivo testing and characterization including biocompatibility and sterilization.

Lead the engineering and manufacturing teams to develop clinical samples to conduct animal clinical studies.

Led animal implantations & clinical studies through Skirball Center for Cardiovascular Research Foundation.

Bioteknica Inc. Coral Gables, Florida 05/2004 to 12/2010

A consulting firm specialized in engineering, quality, and regulatory projects catering to medical device, pharmaceutical, and biotechnology companies.

Independent Quality Engineering & Regulatory Affairs Consultant QMS / FDA Remediation

Managed cross functional teams to address and mitigate regulatory warning letters and consent decree.

Supported product/process optimization and validations, for new and existing product lines.

Beckman Coulter –Kendall/ Barracuda (CDR90)

Johnson & Johnson-Cordis Miami / Cardiovascular PQS Cypher Elite RX MPRC

Boston Scientific-Doral / Project Horizon

Johnson & Johnson-Cordis Miami /NPD Cardiovascular, Endovascular, Neurovascular Divisions

Smiths Medical-Keene New Hampshire (multi- site support)

Artisan Remodeling Solutions LLC. West Palm Beach, Florida 01/2002 to 02/2004

An engineering consulting firm focused on full service industrial facility renovation and upgrade.

Managing Director-Cofounder

Developed and executed strategic business plans and timelines including profit and loss statement.

Created a comprehensive project plan for cleanroom environments upgrades, monitoring per ISO 14644-1.

Developed contractual agreements and managed capital projects for lifesciences industry.

Identified, evaluated new business opportunities, and directed project teams.

Alcon Research LTD. Fort Worth, Texas 11/1998 to 09/2001

A Fortune 100 pharmaceutical and medical device company specializing in the discovery, development and manufacture of innovative ophthalmic products and technologies.

Surgical IOL and Therapeutics Research & Development Division

Engineering Manager- Development, Pilot Operations

Managed fourteen team members Pilot Operation department to launch innovative IOLs to clinical studies.

Coordinated multiple projects with cross functional units to launch devices through commercialization.

Developed good working processes with all functional groups to ensure timely product development and adequate documentation per regulatory standards.

Oversaw technical support activities to ensure best possible and practical technical decisions are made.

Created contingency plans to maintain projects on schedule as planned.

Identified and assessed appropriate process technologies for modern designs and concepts.

Improved support processes and systems to ensure efficient product development cycles.

Recruited and trained technical personnel, managed performance appraisal process for the department.

Managed external vendors and technical support groups to support relocation and operation of pilot operations, and clean room processing labs.

Mehrdad Mike Shokoohi

2191 N. Australian Ave. #605

West Palm Beach Florida 33407

**********@***.***

Phone: 305-***-****

Endologix Inc. Irvine, California (formally Cardiovascular Dynamics) 05/1996 to 09/1998

Private capital venture medical device organization specialized in developing and manufacturing minimally invasive treatments of abdominal aortic aneurysms.

Director of Engineering- Research & Development / Chief Technology Officer

Led the R&D department through three platform designs at 48% under planned

Developed of a self-expanding endovascular prosthesis for treatment of abdominal aortic aneurysms.

Coordinated with cross functional teams to implement development strategies through commercialization.

Identified, recruited, trained technical talents, and fostered teamwork throughout the organization.

Managed the intellectual property and interfaced with the IP council for patent protection strategies.

Worked closely with the vice president of marketing establish product profiles and development priorities.

Interfaced with physicians to evaluate clinical performance of the devices and experimental models.

Participated in the private capital fund raising efforts and due diligence processes.

Explored and initiated licensing, acquisition, and strategic collaboration opportunities.

Cardiovascular Dynamics Inc. (CVD) Irvine, California

A medical device company specialized in developing non-invasive medical devices for treatment of cardiovascular diseases.

Engineering Manager- Manufacturing & Operations

Orchestrated the rapid manufacturing scale up and product transfers for initial public offering in 1996.

Developed and structured the Manufacturing Engineering and Production departments.

Managed the Manufacturing and Production departments with sixty team members strong.

Created the Pilot Production Line and the support teams to accelerate product development cycle.

Launched three platform products from the R&D prototype stage to full-scale manufacturing.

Initiated design enhancements in compliance with GMP and ISO 9001 standards.

Implemented the Lean and JIT manufacturing systems and information mapping procedures.

Established on line product reliability testing and process capability program.

Improved the production throughput from 60 to 289 units per day within six months.

Advanced Cardiovascular Systems (Guidant/Abbott) Temecula, California 01/1990 to 05/1996

A fortune 100 company specialized in implantable, diagnostic, and therapeutic devices for treatment of cardiovascular diseases.

Sr. Manufacturing Engineer

Transferred/sustained PTCA system including catheters, guide wires, guiding catheters, and stent delivery.

Supported R&D during the design phase to ensure product manufacturability.

Formulated and managed project transfer plans from R&D stage, to manufacturing ramp up.

Developed manufacturing procedures and processes per Lean JIT systems.

Performed product and process validations including statistical process capability analysis.

Developed and executed design of experiment studies to improve device Performance and improve yield.

Re-Engineered some of the processes to eliminate non-value-added operations and delays.

Quality Assurance Engineer (1990-1992)

Supported new product/process start-up and technology transfer from R&D stage market release.

Investigated field complaints and formulated corrective actions on manufacturing problems.

Performed design/process enhancement studies to improve product safety/efficacy.

Implemented on-line functional evaluation of finished goods and established pre and post sterilization specification

Developed validation protocols in compliance to GMP/ISO 9001 standards.

Performed process/inspection capability analysis to establish process limits.

Developed quality, and inspection procedures for new and existing products.

Mehrdad Mike Shokoohi

2191 N. Australian Ave. #605

West Palm Beach Florida 33407

**********@***.***

Phone: 305-***-****

Education

Bachelor of Science in Industrial Engineering & Technology, Emphases on Manufacturing

California State University Long Beach, California

Associate Degree in Arts

Rio Hando College Whittier, California

Internships

Baxter Edwards Inc.

Baxter Bentley Inc.

Apple Computer Inc.

Ericsson Communication Inc.

Calcor Space Facility Inc.

Patents

US 8,945,201 B2 US 8,317,857 US 8,303,650 US 6,077,296 US 6,331,190 Japan 4,143,749 US 7,520,895

US 7,892,277 Canada 2,335,333, Germany 69,933,560.4 France 1,087,729 United Kingdom 1,087,729

Japan 4,377,546 US 2011/0,224,782 A1 US 2013/0060327

Professional Development

DOE, SPC, Risk Management, Process/Product Validations, Software Validations, FDA Regulations, Bioteknica consultant annual training programs 2005, 2006, 2007, 2008, 2009

Mining Group Gold 2001

Management Practices, Alcon Laboratories 2000

Human Recourses Policies & Procedures, Alcon Laboratories 2000

Team Action, Development Dimensions International Inc. 2000

Spencer. Shanks. Capers Inc. Leadership Process: Communication Model PCM 1999

Peripheral Angioplasty, the 7th Annual Ochsner New Orleans Louisiana 1998

Endovascular by type of procedure, International Congress Arizona Heart Institute Foundation 1998

Polyethylene Terephthalate PET properties & processing, the University of Toledo Div. of Continuous Education. 1995

AB lasers Inc. System Maintenance and Operation, 1994

Just in Time and Management, Lean Manufacturing Guidant Inc. 1994

Design of Experiment, Stat Ease Inc. 1994

Variation Simulation Analysis Software VSA, Applied Computer Solution Inc. 1993

Power Speaking 1992

Social Style Series,Wilson Learning 1991

Achieving Excellence through Teamwork, ACS 1990

Cardiovascular Systems Field Education and Development, ACS 1990

1220 Automatic Non-Contact 3-Dimensional Measurement System, View Engineering Inc. 1989

Solving plastics problems with modern analytical methods, Technology & Venture Div. 1989

Just In Time for America, the Forum LTD. / Handley Walker Management Company 1989

Society of Manufacturing Engineers, scientific knowledge in the field of Manufacturing Engineering 1986

Community Involvement

United Way

American Heart Association

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