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Medical Device Engineering

Draper, UT
October 30, 2019

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Tajila Mullahkhel 801-***-****

***** *** ********* *****, ******, UT 84020 Professional Profile

Skilled chemical engineer with diverse experience across process engineering, project management, R&D, and sustaining engineering. Proficient at conducting Design Control and Risk Assessment on Class II Medical Device, change control and manufacturing process design. Adept in developing, implementing, and managing multiple projects within time and budgetary constraints. Effective communication skills and ability to distill complex ideas into straightforward language. Proficient in organizational infrastructure, regulations, and stakeholder engagement. Skilled in preparing detailed documents and reports while managing other responsibilities. Skills

Product design and development, conducting design control on new and legacy products. Design and use FMEAs, 510(k) submission of medical device, manufacturing process improvements, DOE experiments and analysis, statistical data performance and analysis, creating DHFs for new and existing products, gap analysis, CAPA initiation and execution, expert at using project management tools such as Microsoft Project and Smartsheet. Project budget and planning, pre and post market analysis, project planning and execution, managed project team of engineers and technicians. Fluent in speaking 5 different languages. Professional Accomplishments

Project Management, Fresenius Medical Care North America Dec 2015 - Dec 2016

• Management global project cross-functional team

• Project planning resource and budget analysis

• Constructed project schedule and timeline

• Generated and maintained product Design History Files (DHFs)

• Planned and managed global project(s) of large scale (>$200 million)

• Led design and multinational rollout of robust therapy system for acute kidney care

• Produced high quality deliverables that met project timeline Sustaining Engineering, Fresenius Medical Care North America Jan 2014 – Dec 2015

• Design and change control

• Added design changes to legacy products to keep up with quality and market needs

• Successfully completed process improvement project(s)- upwards of $1.4 million savings

• Effectively synthesized medical grade polymer to integrate in legacy products for Improved performance

• Proposed design improvements to legacy products –upwards of $650 M savings

• Implemented process modifications, improved efficiency by 10%, upwards of $650K

• Initiated and executed CAPA(s)

• Developed design test protocols and reports

• 510k submission

• Design History File creation for existing products-gap analysis Process Engineering, Fresenius Medical Care North America May 2013 – Jan 2014

• Worked with design group to develop reaction parameters to design a reactor for polymer production

• Synthesized medical grade polymer for quality membrane performance

• Constructed fiber membranes for filter design and development

• Experienced with reactor mixing, compounding, and filtration processes

• Developed reaction parameters using pressure and temperature to increase product yield and cut reaction time by 45%.

• Used chemical and engineering principals of reactor design and thermodynamics Associate Professor, University of Utah Aug 2010 – Nov 2015

• Worked as an associated professor in University of Utah to teach defense language courses within an aggressive timeline.

Research Assistant University of Utah Aug 2011 – Dec 2013

• Used biomimetics in developing artificial fascia tissue.

• Utilized principals of science, engineering and biology to develop biological materials. Education



University of Utah, SLC, UT Dec 2013


References are available upon request.

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