Product Development Project Management

Majdi F. Shomali

**** *. ******** **, *********, VA 22201

Cell 703-***-****

https://www.linkedin.com/in/majdishomali

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

Summary of Qualifications

• Management of Product Development Projects, Engineering, Operations, Quality and Regulatory Affairs functions in Medical Device Companies.

• Engineering, Product Development and Project Management experience in the Instrumentation, Lab Equipment, Sensor, Automation, Indoor Air Quality, Safety/Gas Detection and Homeland Security Industries using state of the art development tools and processes.

• Award winning technical new product development electronic hardware/software/mechanical/optical experience.

• BS Electrical Engineering and MBA degree earned with high honors.

• Design for Six Sigma, Lean Sigma, Process development and leading change in organizations experience.

Education

Duquesne University, Pittsburgh, PA

• Masters in Business Administration, 2006, Graduated with High Honors

University of Pittsburgh, Pittsburgh, PA

• Bachelor of Science in Electrical Engineering, 1986, Completed five post baccalaureate courses in software engineering

University of Michigan, Ross Business School through Coursera, 2016

• Certificate in the Leadership Specialization Series: Inspiring and Motivating Individuals, Managing Talent, Influencing People, Leading Teams

Employment

(October 2013 – December 2016) Eniware, LLC. Bethesda, MD

VP Product Development

• Established the Product Development, Project Management, Engineering, Quality and Regulatory functions and organizational structure in a start-up environment that is tasked with developing and bringing to market the next generation portable sterilization systems.

• Implementation of new product development processes, project management and the quality management system needed for effective medical device development to meet international standards: IEC61010, IEC62304, IEC62366, ISO14937 and ISO14971.

• Identified key suppliers/partners and established global supply chain.

• Key member of the management team.

• Risk analysis, management and mitigation.

• Oversight of contract services - testing and manufacturing.

• Intellectual property portfolio development.

• Developed budgets and managed to meet financial objectives.

• Development, training and mentoring of technical personnel.

(January 2007 – October 2013) American IV Products, Inc. (AIV, Inc.), Harmans, MD

VP Engineering and Operations

• Responsible for Engineering, Product Development, Project Management, Production, Quality and Regulatory Affairs in an ISO 13485 registered medical device company.

• Managed operations to meet financial targets.

• Developed processes for new product development to transform a repair and service facility into an organization with new product development as a core competency. Product lines included fetal monitoring transducers, pulse oximetry sensors, drive systems and components for infusion and auto-syringe pumps, hospital grade power distribution to meet international standards: IEC60601, IEC62304, IEC62366, ISO14937 and ISO14971.

• Identified key global suppliers/partners.

• Identified staffing requirements and recruited personnel to meet organizational goals.

• Developed department budgets and tracked expenditures.

• Interfaced with off-shore medical equipment manufacturers and established procedures to increase collaboration efficiency and decrease product time to market.

• NPD Core Team Member.

• Received 510(k) approvals for three product lines and UL Agency approvals for 4 products.

(May 1994 – December 2006) Mine Safety Appliances Co. – Instrument Division (MSA), Pittsburgh, PA

Sr. Staff Engineer/Technical Project Leader, New Product Development

• Lead multi-organizational high profile technology development efforts to develop new products for the Safety/Gas Detection and the Homeland Security markets:

- Infrared sensors and systems used to protect high value petrochemical facilities and offshore platforms.

- Sensors and instruments for deployment in Classified / Explosive environments to ANSI/ISA and ATEX standards.

- Deployable multi-threat detection system for New Year’s Eve, Kentucky Derby and Superbowl Events.

- Permanent multi-threat detection installed in the Pittsburgh Metro System.

• Lead projects to develop key technologies with target partner startup firms and integrate into company product lines.

• Developed automated analyzer calibration system and PLC based gas detection / control systems.

• Developed signal processing and sensor interference detection algorithms.

• Presented written and oral reports to executive management.

• Employed state of the art NPD tools – Design for Six Sigma, Phase/Gate process, DFMEA, Lean Design, Pugh Concept Selection, Theory of Inventive Problem Solving, Microsoft Project.

Intellectual Property

• Patent - Method for interfacing with infrared instruments in classified environments, US Patent 7,132,659.

• Patent - Relocatable power tap for use in a patient care areas, US Patent 9,543,692.

• Two additional patents pending and submitted invention records that are the basis for company trade secrets.

Publications

• Sterilization in Low Resource Environments Using Nitrogen Dioxide Gas, Public Library of Sciences, 2015.

Awards

• Quality System ranked #2 in Quality Magazine Top 100, 2009.

• Frost & Sullivan Award for Technology Innovation, 2005.

• Processing Magazine, Breakthrough Product of the Year, 2005.

• Sensor Magazine, Top 50 Products, 2006.

• Control Magazine, Reader’s Choice Award, 2005, 2006 and 2007.

Professional Affiliations

• Member of the Institute of Electrical and Electronics Engineers (IEEE) and the Engineering in Medicine and Biology Society (EMBS).

• Member of the Project Management Institute (PMI).

• Member of the Association for the Advancement of Medical Instrumentation (AAMI).

• Member of Beta Gamma Sigma, honors society for accredited business school programs.

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