Engineer Project Manager

Hiwa Nezhadian

Granada Hills, CA *****, (*****@***.***), H: 818-***-****, C: 818-***-****

Summary

Project Management, Design & Development, Cost Reduction, Validation/Qualification, Risk Analysis, Certified Quality Auditor, & 6 Sigma/QFD Green Belt, A&P License

Multi-disciplined, result oriented Engineer/Project Manager with over 20 years of experience working with cross functional team of R&D, manufacturing, quality and regulatory in medical, aerospace, and commercial industries. Product development from concept through production, and product commercialization. Proven track record in root cause analysis, risk analysis, manufacturing assembly procedures, test procedures, and report writing. Redesigns for quality improvement, cost reduction, field failure reduction, and increase in customer satisfaction that have resulted in millions of dollars of savings.

Certifications

Certified Quality Auditor (CQA) from American Society for Quality.

Six Sigma/Lean Sigma Green Belt certificate from Medtronic Inc.

Quality Foundation Deployment (QFD) from Medtronic Inc.

Aircraft Airframe and Powerplant Certificate (A&P License)

Education

Bachelors of Science in Mechanical Engineering (BSME), Calif. State University, Los Angeles

Graduate Courses in Mechanical Engineering (MSME), Calif. State University, Northridge

Masters in Business Administration (MBA), University of Phoenix, Phoenix, AZ

Areas of Expertise:

- Lean/6 Sigma, QFD Green Belt - Risk Analysis, FMEA - Conceptual Design, R&D

- IQ/OQ/PQ, Process Validation - Minitab, Medstat, DMAIC - ACAD, CATIA, Solid Works

- SAP, Agile, EQDMS - CPI, TQM, CAP - ISO 14971 / 13485, EN 60601

- New Product Development - Project Management - Competent Toastmaster

- Patents (US/International) - Certified Quality Audit (CQA) - Voluntary Works

Professional Experience

CONSULTANT 2015-2016

Principal Quality Engineer/Project Manager

Consulting for commercial and life science industries in preparing quality documentation, root cause analysis and mitigation. Writing qualification, validation and life cycle test procedures. Provide technical solutions to enable clients to meet financial objectives throughout product development.

MEDTRONIC MINIMED, Northridge, CA 2005 - 2015

Senior Quality Assurance Engineer

Product and Process Qualification, risk analysis, Design / Process FMEA, feasibility test procedures, design verification and validation. Root cause and product complaints investigation and solutions in a regulatory environment. TnP test of plastics to determine molded-in stresses. Design control, risk management, process validation and qualification of device/drug combination, participated in FDA, GMED and UL audits as an SME (subject matter expert).

Led cross function teams and executed several CAPA (Corrective And Preventive Action) projects:

Redesigned, developed and launched a device with increased reliability and reduced cost. Reduced monthly failure rate from 1200 down to under 10 units, which resulted in $320K annual savings and increased customer satisfaction.

Based on Lean Sigma/6 Sigma analysis, improved the design and manufacturing processes of a sensor that resulted in $1.5M annual cost savings and reduced rate of return by 75%.

Developed mechanism that eliminated field failure that could result in harming end users.

KARL STORZ ENDOSCOPY NORTH AMERICA, Culver City, CA 2002 – 2004

Senior Research & Development Engineer

New product development from concept through prototype and production. Designed and developed medical and surgical devices: dissectors, pliers, graspers, bipolar forceps, ergonomic flashlights, endoscope accessories, linkages and mechanisms. Selected material, supervised manufacturing processes, inspected, assembled, tested, and prepared final models for field trial. Analyzed results and prepared for production.

Designed and developed a Dual Battery Portable Swivel Light Source used by medical professionals that was more ergonomically friendly than traditional ones (Used Solid Works).

Redesigned and developed a Bipolar Forceps from European version to US surgeon’s requirements (Used Solid Works).

HELIX MEDICAL, Carpinteria, CA 2002

Senior R&D Engineer /Project Manager

Managed and followed up on progress of the design, prototype fabrication, testing and field trial of voice prosthesis implants made from silicone. Prepared process protocol charts, monitored DHF.

MEDTRONIC MINIMED, Sylmar, CA 1996 – 2001 Research Engineer (1999-2001)

Based on redesign and innovative ideas in manufacturing, was recruited to Advanced Engineering Department to join a small group of engineers, commissioned to conceptualize and develop new products. Designed, developed and tested future minimally invasive medical devices in the field of diabetes and areas of chronic conditions that require continuous drug delivery.

Conceptualized a gas-operated mechanism for liquid microinjection systems.

Designed a Micro Infusion Pumps (Patented).

Changed a plating process that resulted in $600K annual savings.

Manufacturing Engineer (1996-1999)

Managed multiple projects, resolved day-to-day manufacturing issues, redesigned components that resulted in increased reliability, decreased field failure and increased customer satisfaction. Developed fixtures and tooling, value analysis, material engineering, laser welding, and application of different manufacturing techniques and processes for insulin infusion pumps for diabetes.

Audited vendors for quality, documentation and manufacturing capabilities. Led cross-functional teams. Authored Engineering Reports and Process Validation Protocols, initiated a number of projects:

Eliminated field return by redesigning a mechanism that resulted in $660K annual savings.

Redesigned Capacitance Discharge Solenoid Operated Electric Motor to replace outdated design, reduced costs by 30% and increased force efficiency by 36% (Patented).

GM ENTERPRISES, Walnut, CA 1995-1996

Sr. Project Engineer

Designed and monitored the development of heat treating equipment: vacuum furnace, atmospheric furnace, quinching systems and heat exchangers. Prepared detail and assembly drawings, procured raw material, provided floor plan layout, and manufacturing follow ups.

ROCKETDYNE, DIVISION OF ROCKWELL INT’L, Canoga Park, CA 1988-1994

Lead Engineer

Managed a staff of eight engineers, responsible for design, release of drawings, resource allocation and development of ground support equipment for transfer of Space Station Powers Module to testing and launch sites.

Increased design productivity of the team by 54% in nine months by implementing processes to remove bottlenecking.

Outstanding Award for inventing “Softlock Mechanism”.

Sr. Member of Technical Staff

Designed spacecraft structures, hypersonic systems, spacecraft attitude control engines, mechanical actuators, liquid propellant rocket engines, Space Based Interceptor, robotic mechanisms and linkages for International Space Station Alpha. Used cryogenic materials, super alloys and processing for high performance and durability in outer space. Provided material selection, prototype development and manufacturing follow-ups.

Technology award for design of “Soft Lock Mechanism” for International Space Station Alpha.

ACME DIVAC INDUSTRIES, Gardena, CA 1984-1988

Chief Engineer

Started as a Design Engineer responsible for design of aircraft switching devices and assemblies, landing gear control panel, air flow switches, cabin depressurization valves, air solenoid valves, air and liquid filters. Promoted to chief engineer responsible for Engineering, Production, and Quality Control departments and prepared quotation for new businesses. Managed a staff of 18.

Reduced cost of production by 32% and increased reliability through design and manufacturing process changes.

Increased sales and annual revenue by 35% through appropriate resource allocation and reduction in cost of manufacturing and cost of Poor Quality.

Patents

Medtronic-MiniMed patent awards for the following medical devices:

External Gas Powered Programmable Infusion Device, patent number 6,458,102.

Gas Generating Cell for use in disposable drug delivery systems. Patent File # PD-0395.

Mini-patch Disposable Drug Pump, Patent File # PD-0451.

Compact Pump Motor System and Dispensing Process, patent number 6,554,800.

Drive Nut Mechanism, Patent number 4,685,903.

Professional Membership

Member of American Society for Quality (ASQ)

Alumni member; California State University at Los Angeles

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