Engineering Medical Device

Gokce (Geena) Polack

*** *** ******, **** *, Garfield, NJ 07026

Email:*******@*******.*** Cell Phone: 201-***-**** LinkedIn: www.linkedin.com/in/gokce-polack

Education:

Stevens Institute of Technology, Hoboken, NJ

Masters of Science in Bioengineering, full-time student, GPA:3.918 Expected Dec 2018

Rutgers University, New Brunswick, NJ

Bachelor of Science in Biomedical Engineering (High Honors), GPA: 3.632 May 2017

Experience:

Stryker, Allendale, NJ

Regulatory Affairs Intern 5/21/2018-ongoing

Analyzing divisional Master Attribute Files to determine key metrics and utilizing Power BI to represent key metrics in visual charts.

Working on creating a draft for Declaration of Conformity (DoC) with the Sr. Director of Regulatory Affairs.

Reviewing and gathering information on ISO 13485, ISO 9001 documents and BSI contracts to assess opportunities for improvement.

Working with Divisions, Workstreams and EU-MDR core team to create the EU-MDR Newsletter.

Working on creating a draft for Technical file procedures in compliance with MDR.

Utilizing Microsoft Excel to generate the Master file for AdvaMed Committee Members.

Attending training sessions and conferences about new European Union Medical Device Regulations (EU-MDR) and working cross-functionally with other departments.

Prepared a presentation for the communication and brainstorming session in the EU-MDR face to face meeting.

Advanced Accelerator Applications, Millburn, NJ

Quality Assurance and Control Intern 9/2017-12/2017

Attended training sessions in quality control laboratory to learn basic radiopharmaceutical quality testing techniques such as pipetting, balance, pH calibration, HPLC (High-performance liquid chromatography), ITLC (Instant thin layer chromatography) and surveys.

Generated and printed labels for released products and attached the labels to the corresponding products.

Prepared SOPs and graded training documents.

Checked the inventory and prepared an inventory list of products using excel worksheet.

Conducted Class C and Class D level environmental monitoring using particle counter in cleanrooms.

Researched and created a presentation on “Hypothesis of Radiation Hormesis.”

Columbia University Medical Center, New York City, NY

Visitor Research Student, Radiology Department 6/2017-8/2017

Involved in two research projects titled “Correlation of Quantitative SPECT-CT with Planar Imaging in Liver-Spleen Imaging for Ovarian Cancer Patients” and “Quantitative analysis of a new Phantom with SPECT-CT and PET-CT”.

Conducted a statistical analysis of data to investigate the correlation between SPEC-CT and planar imaging.

Utilized Hermes software on reconstruction and correction of phantom images.

Skills:

Experience with Cell Culture, Electrospinning, Flow Cytometry, Immunostaining and ELISA

Proficient in Microsoft Word, Microsoft Excel, and PowerPoint

Programming Experience in MATLAB.

Foreign Languages: Turkish (Fluent), German (B2 certificate, Intermediate Level)

Quality Control, Quality Assurance, Regulatory Compliance, GLP, cGMP

Academic Projects:

Stevens Institute of Technology, Hoboken, NJ

Master Research Project 8/2017-ongoing

Writing a review paper related to the role of macrophages in chronic wound healing.

Culturing macrophage-like cell line derived from Balb/c mice (RAW 264.7).

Attended training sessions in tissue reconstruction laboratory to learn cell culturing, electrospinning and immunostaining techniques.

Cultured Human Glioblastoma Cells (G55).

Rutgers University School of Engineering, New Brunswick, NJ

Senior Design Project 9/2016-4/2017

Worked as part of a team under the supervision of Dr. Drzewiecki in BME (Biomedical Engineering) Devices Laboratory on designing a tactile transducer that will improve limb sensation.

Rutgers University School of Engineering, New Brunswick, NJ

Undergraduate Research Student 9/2016-5/2017

Utilized MATLAB and “3DSLICER” for segmentation of brain images.

Honors:

Rutgers University Deans List. Spring 2017

Rutgers University Magna Cum Laude Honors. Spring 2017

Phi Theta Kappa Honors Society Spring 2014

The Judith K. Winn School of Honors Dual Honor’s Certificate. Spring 2015

Provost Master Fellowship Fall 2017

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