Medical Device

Keyoumars Imaninaini

Cell: 651-***-****

Experience:

Experience with Class II and Class III medical devices/drugs of interest

Method Validation, IQ, OQ, PQ, DQ, medical device manufacturing quality system requirements.

Conducting compliance audits of complex documentation and data.

Controlled document Lifecyle processing.

Administration, filing, maintenance, retrieval, issuance, and destruction activities.

Experience following GLP, GMP, and QSRs guidelines identifying and initiating CAPA activities investigation (deviations, laboratory documentations).

Class II (510) K and Class III PMA medical device submissions experience

Familiar with US and International regulatory standards for medical devices.

Reviewing and assessing change control, validation and qualification documents.

Skilled in making experimental observations, decision making, providing effective solutions, and organizational management.

Extensive medical education in basic medicine, heart failure, and kidney disease.

Molecular Biology techniques involved in biological testing techniques and

Biocompatibility testing of raw materials and finished products for medical devices such as LAL, endotoxin, sterility, pyrogen, and cell culture.

SPECIAL INTEREST AND RESEARCH

(510), PMA submissions of class, II and III medical devices to FDA.

FDA regulatory standards, QSR, 21CFR 830, ISO 13485.

Molecular, Biological research and techniques.

Biocompatibility testing.

Quality Control inspector for medical devices.

Clinical trial studies.

PROFESSIONAL SUMMARY

Extensive medical device, drugs clinical research and molecular biology background characterized by discipline and leadership.

Cell culture experience with mammalian cell, and stem cell.

Writing clinical study protocol.

Skilled in making experimental observations, decision making, providing effective solutions, and organizational management.

Medical device reporting (MDR) and Adverse Drug Experience Report (ADR).

Experience with Class II and Class III medical devices/drugs of interest

Expertise with medical devices and pharmaceutical drugs clinical studies which include: IDE, PMA, 510(K), CE Mark, international and US regulatory submission requirements, site selection, monitoring, auditing, IRB, CRO and FDA.

Extensive cell culture work experience. GMP, GLP certified.

Laboratory research and protocol writing experience.

Molecular Biology Techniques expertise in mammalian cell culture.

PMA clinical trials submission to FDA medical device class III Drug Coated Stent.

Strong computer skills with proficiency with MS Windows Office based applications.

Molecular Biology techniques expertise, PCR, DNA extraction and data analysis.

Biocompatibility testing of Medical devices and chemical analysis raw materials.

TECHNICAL SKILLS

Established Particulate Counting Method of medical devices.

Experience working under FDA/ISO regulated environment ensuring compliance to FDA and ISO requirements, review and approval of Quality System documents, and QSR.

Writing and reviewing final reports, standard studies and documentations.

Experience following GLP, GMP, and QSRs guidelines identifying and initiating QA and CAPA.

Conduct GLP critical phase audits and complete documentation.

Machine operation skills.

Involved in new medical device Catheters and Stent design for manufacturing and test methods.

Major contributor to Stent research and development global industry.

Partial author of USP 71 standard of medical device particulate testing.

Biocompatibility testing experience of medical devices.

Designing case report forms and Investigational site selection

Monitoring clinical studies at multiple sites and traveling to the sites as often as required.

Identifying and contacting potential investigators.

Strong working knowledge of Good Clinical Practices (GCP), FDA regulations, and current industry practices related to the conduct of clinical trials.

Reviewed the reporting related to MDR or ADR using AS300 software methodology.

In-depth knowledge of medical terminology/concepts related to medical devices.

PROFESSIONAL EXPERIENCE

Microbiologist, Biocompatibility and Sterilization Associate Medtronic, Brooklyn Park, MN

11/20/19 – 6/2020

Worked closely with internal R&D teams and external labs to design biocompatibility assessment strategies.

Ensured that adequate documentation existed for all the new and existing products to meet the existing and emerging regulatory requirements, particularly the EU Medical Device Regulations (EU MDR) and ISO 10993.

Coordinated recommended biocompatibility testing with external research labs, and assessing applicable test data Planning, leading or supporting protocol development, study management, data analysis and reporting of data.

Wrote Biocompatibility Assessment Reports.

worked closely regulatory affairs, quality engineering, and manufacturing to support projects that need biocompatibility assessments.

Understanding of EO residual, EO tolerable contact limit, D-Value, and SAL.

Coordinated annual EO sterilization cycle revalidations.

Developed and executed product sterilization validations.

Coordinated biocompatibility evaluations.

Created reports for quarterly radiation dose audits for product families.

Managed and coordinated projects with external sterilization organizations.

Quality Control Inspector TapeMark St. Paul, MN

11/2018 – 11/2019

Responsible for acting consistently with Tapemark values of Excellence, Responsibility, Integrity, Community, Knowledge and Attitude to ensure the organization’s effectiveness and success.

Responsible for audits and inspection to assure ISO 9001/13485, cGMP, TM and customer requirements are met.

Operation of machines in making of pharmaceutical drugs.

Conduct in process inspections and start up audits to assure manufactured products are conforming to customer requirements.

Review operations documentation ensuring compliance with cGMP, ISO9001/13485, FDA, regulations and customer requirements.

Work closely with operation manufacturing records and production batch records to ensure compliance of all regulations.

Initiate MRR’s and Incidents for non-conforming raw materials and finished products.

Verify that all test data is correct, complete, and files are updated with all necessary documentation.

Communicate with outside vendors, co-workers, supervisors, managers and other departments about barriers and solutions in a professional manner.

Coach operations staff on QA requirements.

Quality Assurance Inspector Baxter International, Brooklyn Park, MN

11/2017 –11/2018

Responsible for acting consistently with Baxter values of Excellence, Responsibility, Integrity, Community, Knowledge and Attitude to ensure the organization’s effectiveness and success.

Responsible for audits and inspection to assure ISO 9001/13485, cGMP, TM and customer requirements are met.

Conduct inprocess inspections and start up audits to assure manufactured products are conforming to customer requirements.

Review operations documentation ensuring compliance with cGMP, ISO9001/13485, FDA, regulations and customer requirements.

Work closely with operation manufacturing records and production batch records to ensure compliance of all regulations.

Initiate MRR’s and Incidents for non-conforming raw materials and finished products.

Verify that all test data is correct, complete, and files are updated with all necessary documentation.

Communicate with outside vendors, co-workers, supervisors, managers and other departments about barriers and solutions in a professional manner.

Coach operations staff on QA requirements.

Quality Control Associate Lake Region Medical Chaska, MN

10/2016 – 11/2017

Performed QC testing, test method validation SPC data analysis.

Final approval of product release to operations and manufacturing for building products.

Reviewed standard operating procedures (SOP’s), to include asset care, and preventative maintenance requirements.

Made changes to SOP when required to update process validation.

Consulted with supervisors and managers for any QC tests issues.

Initiated MMR and documents for nonconformance and out of process activities.

Using utmost care and discretion in handling extremely fragile and costly product

Interacted with all team members to maximize production and quality.

Advanced Manufacturing QA Associate Beckman Coulter Chaska, MN

11/2015 – 10/2016

QC testing of Access 2 Instrument Manufacturing Acceptance Testing (IMAT) required releasing an Access 2 Instrument within Manufacturing.

Instrument Setup and configuration. In -Process Acceptance Activities Review.

Performed Test Analysis and complete QC testing on Access 2 Immunoassay Instrument.

Worked directly with Instrument Manufacturing Technicians, Engineering, and Quality to troubleshoot Instrument related issues on the manufacturing floor.

Assisted engineer’s complete product performance qualification testing per protocol requirements and quality management system standards.

Actively provided ideas and feedback to support process, product, and organizational improvement initiatives (continuous improvement).

Gathered and organized data to support investigations, feasibility studies, assisting the engineering

Regulatory Compliance Specialist Bio Vest International Coon Rapids, MN

7/2014 – 11/2015

Developed Quality Management Plan (QMP) that documenting the management and operational policies and procedures to ensure work processes, products, or services satisfy expectations and quality standards.

Provided quality assessment plans to evaluate and improve quality of maintenance production and work processes.

Conducted evaluations to identify strength problem areas, failure trends, faults in methods and procedures, and other deviations from quality standards.

Prepared quality assurance operating instructions, local forms, checklists, and other material.

Reviewing quality outputs for compliance to internal and external requirements (21 CFR 820, ISO 13485, ISO 14971, ISO 9001, etc.).

MDR/Vigilance Specialist contract American Medical Systems (AMS), MN

4/2013 – 7/2014

Completed and submitted regulatory reports within the timeframe mandated by FDA.

Facilitated complains communication to assess for regulatory reportability and potential impact to patient safety and business operations. Evaluated and identified complains.

Investigated complains by gathering enough data from reports, clinical staff, doctors, hospitals and laboratory analysis at AMS.

Participated in developing strategies for regulatory reporting decision using event investigation and regulatory decision models.

Developed internal system, methods, and procedures to maintain compliance and support post market surveillance.

Participated with writing and developing decision models with changes in product advances or therapies to uphold consistence with mandated regulations under general supervision.

Assistant Scientist University of Minnesota, Minneapolis, MN

2007 – 4/2013

Performing molecular biology techniques, including DNA isolation from whole blood and buccal cells, sample tracking, the polymerase chain reaction and SNP analysis.

DNA genotyping for polymorphisms (SNP) using the polymerase chain reaction, TaqMan analysis and other forms of genotyping.

Flow cytometry analysis of extracted lymphocytes from blood of patients.

Reported adverse findings of post heart attack WBC to IRB within the hospital and the sites.

DNA extraction from Blood and Saliva used for genotyping in Twin Family Study Research at the Department of Psychology Behavioral Genetics.

Maintained cell culture line for ongoing research.

Clinical Research Associate (CRA), Boston Scientific, Maple Grove, MN

2003 – 2007

Involved in on-going Preclinical Research animal studies, focused on treatment of coronary artery disease. Contributed to TAXUS Stent program in Preclinical study trials

Maintained adequate knowledge and understanding of current scientific literature required to support all product lines and related pre-clinical studies.

Served as the Pre-Clinical representative on assigned project teams and participated in team decision making.

Provided clinical and pre-clinical guidance, strategy, and support for the development of new technologies, new products, extended products claim, and pre-clinical foundation research.

Morphometry analysis of histology slides.

Worked with BIOQUANT medical investigational computer software in image captured analysis.

Tracing IEL, EEL and Lumen of stented coronary arteries (LAD, LCX, RCA, and LCA).

Worked with histology laboratory to prepare slides for morphometry.

Used software BIOQUANT computer to measure the growth percentage (restenosis) of neointimal tissue.

Microbiologist (Medical Device), Boston Scientific, Maple Grove, MN

2000 – 2003

Principal investigator for Laser Liquid Particle Counting.

Performed computer software validation IQ/PQ for Hiac/Royco Laser Liquid particle counter.

Wrote and executed protocol for software validation. Communicated in technical writing with manufacturing and R&D Departments.

Established and trained particulate testing of medical devices according to Unites States Pharmacopeia (USP) 71 standard for the first time in company history.

Determined the number of particulates resides inside and outside of medical devices.

Used microbiological testing for microbial I.D.

Involved in biocompatibility testing of medical devices including: Bioburden testing, Ethylene Oxide, e-Beam sterilization, ISO standard for gamma and electron-beam sterilization. Sterility test, in-house environmental monitoring (EM), Cytotoxicity and Pyrogen testing.

Clinical Research Coordinator (CRC), Abbott Northwestern Hospital, Minneapolis, MN

1995 – 2000

Supervised the progress of the Clinical Trial, ensuring that it is conducted, recorded and reported.

Managed protocol, Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and the applicable regulatory requirements.

Worked with multi pharmaceutical research centers and sites to establish and conduct ongoing cardiac drugs clinical study trials

Determined study objectives, strategy, and scope and schedule in order to meet business needs.

Provided educational opportunities to patients and their families, helped them to understand clinical study trials methodology, safety and FDA regulations.

Designed clinical study trials.

Evaluated data that may be submitted to regulatory authorities.

Tracked and reported progress of studies, including patient monitoring, screening, and data. Collection and adverse event documentation

Reviewed Case Report Forms (CRFs) for clinical content and their accuracy

EDUCATION

Clinical Research Professional (CRP) Certificate

2012, Anoka Ramsey Community College Anoka, Minnesota

Bachelor of Science, Biology

1993, University of Minnesota, Twin Cities

Publication: The Journal of Heart Valve Disease 2016; 16:314-323 Development of a Sheep Model of Atrial Fibrillation and Heart Failure for preclinical trials of Prosthetic Heart Valves.

2006-2016 Post Graduate Continued Education University of Minnesota: physiology and anatomy, medical microbiology, immunology, heart failure and atrial fibrillation, and Medical device clinical trials Class II and Class III.

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