ALBERT ENAYATI

**** ***** **** *********, ** ****2

201-***-**** ad0r9y@r.postjobfree.com

SUMMARY

Principal Research Engineer with 20+ years of experience in R&D, QA, and Regulatory Compliance within the Medical Device Industry. Extensive knowledge of Combination Products, Orthopedic Implants, Bioabsorbable Polymers, Insulin Autoinjectors, Blood Glucose Monitoring System (BGM) and Insulin Pump. Verification protocols were drafted, conducted mechanical testing and issued technical reports on various medical devices to obtain FDA 510 K approvals. Successfully obtained twelve 510K approvals for small joint devices and bioabsorbable devices. Broad knowledge in the FDA 21CFR820.30, budgetary responsibilities, staff supervision and in-depth project management. Working knowledge in QMS and Change Control for given project.

PROFESSIONAL EXPERIENCE

MEDTRONIC, Inc. Northridge, CA February 2023–October 2023

Staff Quality Engineer

Utilized cGMP principles, concepts, practices, and standards, participated in a CAPA activities for remediation of instruments and equipment with Full/Limited Calibration and No Calibration Required to ensure compliance to an approved SOP.

In coordination with Product Support Engineer, successfully addressed 1037 “Certificate of Calibration” for given equipment and instruments.

A total of 1037 Equipment Data Request Form were drafted using Agile and SAP software to identify “Processes Ranges” for given equipment and instruments available in the Master Validation Report (MVR), Equipment and Instruments Travelers and Assembly Process (AP) documents.

Drafted reports for “Out of Tolerance” (OOT) and Non-Conformance (NC) for given instrument and equipment.

As a Staff Quality Engineer approved drafted Equipment Data Request Form for new instrument and equipment to be used in a class eight clean room.

Remediation plan progress reports were communicated to the Medtronic Northridge CAPA Board in a regular basis.

EXELINT International Inc., Redondo Beach, CA December 2022-January 2023

Senior Quality Specialist

Addressed initiated formal CAPAs from the third-party auditor inspection such as drafting User Needs and Design and Development Planning for EXELINT Syringes.

Participated in the EXELINT auditing preparation strategy, reviewed and remediated design control documentation with emphasis on updating the DHF for Design Control Traceability Matrices (DCTM) for EXELINT Syringes.

As the principal back-room participant, assessed, reviewed, and approved any and all the documentation being delivered to the front room before it's given to the inspectors, ensuring fewer surprises and awkward delays or explanations.

AstraZeneca Pharmaceutical, Gaithersburg, MD September 2022- December 2022

Global Quality Specialist

Reviewed and remediated project documentation with emphasis on creation/update the DHF for Design Control Traceability Matrices (DCTM) for Fasenra 30mg/1mL APFS According to their AZ SOPs.

Addressed and/or remediated documentation such as Design and Development Planning, Design Review documents, Design Transfer, Risk Management, PFMEA and DFMEA documents and Design Changes for Fasenra 30mg/1mL APFS According to their AZ SOPs.

Regulatory submissions were evaluated with respect to any product changes to determine if any action is needed.

Remediation completed to ensure all Fasenra 30mg/1mL APFS design-controlled products currently sold or distributed, regardless of where they are manufactured, are complied with 21 CFR 820.30 (Design Control) FDA’s Quality System Regulation (QSR). Remediation was executed by the completion of design control element forms as objective evidence and the resolution of any gaps.

Centinel Spine, West Chester, PA April 2022-July 2022

Senior Quality and Regulatory Affair

Design History Files (DHFs) were integrated from Depuy, Johnson and Johnson Company design and development documents to Centinel Spine DHF requirements and ensured the design, development and marketing activities were in compliance with the FDA design control process. The Prodisc C and Prodisc L Implant family products that were listed in Centiel Spine DHFs were part of acquisitions from Depuy, Johnson and Johnson Company by Centinel Spine.

Drafted IFUs and Labels in compliance with EUMDR for all the Centinel Spine implants such as, Prodisc C, Prodisc Vivo, Prodisc Nova, Prodisc L and all the Stalif C and Stalif L device implants family.

Abbott Laboratories, Sylmar, CA February 2021-February 2022

Senior System Engineer

Responsible for DHF traceability by ensuring all requirements have been verified and validated in Abbott QMS.

Closure of any identified risk gaps for Abbott Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT) systems for EU-MDR submissions utilizing IBM® Rational® DOORS®.

Closure of any identified risk gaps for Abbott Implantable ICD and CRT system leads, for EU-MDR submissions utilizing IBM® Rational® DOORS® using windchill software for change control.

Quality Risk Assessment Analyzed for the patient safety risks associated with Tendril and Durata Defibrillation leads to satisfy EU- MDR requirements.

Analyzed Cyber Security Risks Assessment for ICD and CRT systems, linking appropriate risk to the associated vulnerabilities and identified mitigations for the given risk.

Addressed and/or remediated Cyber Security Risks documentation for a total of 17 Abbott Laboratories ICDs and CRTs system Implants.

System Trace Matrix or other related System Engineering were documented as needed to satisfy EU-MDR requirements utilizing IBM® Rational® DOORS®.

Johnson and Johnson, Santa Ana, CA May 2020 – February 2021

Senior Process Operations Engineer

Participated in reviewing and approving an alternate anodizing contract manufacturing vendor and their process and approving Supplier Change Notification (SCN) and evaluating the risk assessment and supplier capability such as process flow diagrams, part qualification plan, specification review, product implementation and product assessment to manufacturing.

Participate in technical discussions with JJSV approved Tier 1 supplier, Flextronics and approved Tire 2 supplier Golden State Engineering to identify and implement improvements in products and processes reviewing and approving of the First Article of Inspection (FAI) and Incoming Inspection (II) for an alternate anodizing supplier for JJSV PI Cone.

Participated in supplier qualification for a “Like for Like” replacement machining equipment for forming the PI Cone with Flextronics and Golden State Engineering.

Ordered microbiological evaluation on new anodized PI cones in order to verify no impact in Bioburden and Bactria Endotoxin levels are present in final product device as well as no evidence of resistance organism are existing due to introduction of new tools and manufacturing process that could impact the Sterility Assurance Level.

Communicated effectively with cross-departmental in approving new anodizing vendor by drafting Change Impact Assessment Form (CIAF), External Manufacturing & Supplier Quality Change Assessment and Supplier Change Notification.

As a lead Process Operation Engineer, reviewed and approved incubation laboratories vendors with tracking system within JNJ divisions and outside vendors to perform Room Temperature and Accelerated Shelf-life Studies for JJSV product lines.

Reliability tests and failure analysis were conducted by drafting test protocols, performing tests and drafted technical reports for five JJSV packs that were subjected to Highly Accelerated Life Testing (HALT) and determined the mean time to failure (MTTF), how often a device fails and how long it took to fail.

Recommendation was given to utilize ISO 11737-part 2:2019 and ISO 11607-part 1and 2 and use DuPont™ Tyvek® for packaging of JJSV packs for gamma radiation sterilization in vacuumed Nitrogen bed to avoid any oxidation and longevity of JJSV packs.

Participated in performing Root Cause Analysis with outside injection molding vendor to investigate the cracking issue for OPO85 packs.

Effectively performed my assignments remotely with my team members and outside suppliers.

MEDTRONIC, Inc. Northridge, CA June 2019–March 2020

Senior Operations Engineer

Engineering Change Control in Agile Product Lifecycle Management (PLM) System and SAP software were drafted and followed all the Medtronic QMS procedures to obtained approvals.

Conducted inventory analyses for Synergy program for utilization and manufacturing coordination with contract manufacturers to optimize their processes for on time delivery.

Conducted weekly capacity and performance analyses with R&D, Operation, Quality departments to ensure forecasts and schedules are aligned and integrated for assembly parts.

Performed engineering measurements and worked with Supplier Quality Engineer, R&D Engineer, Quality Assurance Engineer and Receiving Inspection in approvals of First Article of Inspection and obtaining final product release from MRB for Synergy products.

AMGEN, Inc. Thousand Oaks, CA Oct 2014-April 2019

Senior System Design Quality Engineer

Subject-Matter Expert (SME) in FDA Waterfall Design Control for the Amgen Final Product Technology team in successful Multi-Billion USD launch in Japan followed by Europe and USA of AMG 785 Romosozumab for postmenopausal women with low bone mineral density.

Reviewed and remediated project documentation with emphasis on creation/update the DHF for Design Control Traceability Matrices (DCTM) for all Amgen products.

Addressed and/or remediated documentation such as Design and Development Planning, Design Review documents, Design Transfer, Risk Management, PFMEA and DFMEA documents and Design Changes for all Amgen products.

Drafted requirement documents as per FDA 21 CFR 820.3 and ISO 13485 Design Control Guidance for Medical Device Manufacturers on Combination Products (CP) of Amgen Prefilled Syringes (PFS) and Autotouch Autoinjectors (AI) in EDMQ, IBM® Rational® DOORS® and Agile (PLM).

Drafted design and development planning, Design input, including intended use and user needs, Design output, including evaluation of conformance to design input requirements through Design verification confirming the design output meets the design input requirements, Design validation ensuring the devices conform to defined user needs and intended uses.

Reliability tests and failure analysis were conducted to investigated Nonconformance (NC) of Amgen AI and determine how often a device fails for deficiency of deliver volume at 15 seconds as required per DIR and performed Root Cause Analysis (RCA) engaging Cross Functional Team (CFT) approach.

Reliability tests and failure analysis were conducted for AMG 785 IFU, Primary labels and Secondary labels by drafting test protocols, performing Label verification and issuing technical reports. The test samples were subjected to Highly Accelerated Life Testing (HALT) and mean time to failure (MTTF), how often a device fails and how long it took to fail were determined.

Corrective Action Preventive Action (CAPA) process was initiated and identified cause, took corrective action and prevents recurrence of the root causes.

Test Method Validation (TMV) means established by objective, evidence that the test method for deliver volume consistently produces a desired result required to satisfy the intended use.

Participated in all Amgen internal and external audits related to issued documents to Romosozumab.

Participated in Amgen Design review meetings for Combination Products (CP) such as PFS and AI to obtain approvals from FDA, EU MDR and Japanese regulatory.

Drafted Design transfer ensuring the device design is correctly translated into production specifications.

Commissioned valid medical device standards to implement Design Verification Testing Programs for Amgen AMG 785 combination product utilizing Minitab Statistical Analysis Software Package.

Label verification protocols drafted, conducted actual label verification testing and written technical reports on IFU, Primary Label and Secondary Labels for all Amgen products using windchill software for change control.

ZIMMER, Inc. Parsippany, NJ Jan 2014-Oct 2014

Senior Process Engineer

Reviewed and remediated project documentation with emphasis on creation/update of Design Control Traceability Matrices (DCTM)

Closure of any identified gaps for products released, including performance of IQ, OQ, PQ and thermal deposition process, Gage R&R to verify the accuracy of data in Design History File (DHF).

Addressed and/or remediated documentation for Design and Development Planning (D&D Plan), Design Reviews, Design Transfer, Risk Assessment, PFMEA and DFMEA documents and Design Changes.

Regulatory submissions were evaluated with respect to any product changes to determine if any action is needed.

Remediation completed to ensure all Zimmer TMT design-controlled products currently sold or distributed, regardless of where they are manufactured, are complied with 21 CFR 820.30 (Design Control) FDA’s Quality System Regulation (QSR). Remediation was executed by the completion of design control element forms as objective evidence and the resolution of any gaps.

OSTEORESORB Corp., Los Ángeles, CA 2006-2014

Senior Project Manager

Responsible for Developing Poly Lactide Polymers product line by identifying potential products; conducting market research; generating product requirements; determining specifications, production timetables, pricing and time-integrated plans for product introduction into the marketing strategies.

Designed bioabsorbable bone plates, bone screws and rivet system for hand, foot and Temporomandibular joint (TMJ) implants.

Designed bioabsorbable polymers to meet specifications for degradation kinetics and weight loss over time.

Utilized PolyLactide Polymers, such as Poly (L-Lactide-co-D, L-Lactide) in design and development of bioabsorbable products.

Worked in Aseptic contamination-free manufacturing environment to avoid reproducing or creating any kind of harmful living microorganisms (bacteria, viruses and others).

Designed and developed the necessary equipment related to manufacturing bioabsorbable polymer such as Injection and Compression Mold machines.

Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) were performed to ensure the effectiveness and safety of the machinery and tools utilized throughout the development process.

Applied Minitab Statistical Analysis Software Package to perform Design of Experiments (DoE) and Process Validation

Applied Minitab Statistical Analysis Software Package to perform Measurement Systems Analysis (MSA) and in particular Gage R&R studies to determine the accuracy of measurements for Verifications and Validation testing programs for manufacturing process to determine variation and bias.

Utilized Six Sigma DMAIC Define, Measure, Analyze, Improve and Control methodology to improve manufacturing process.

Prepared design verification matrix, originated qualification and process validation protocols, designed test fixtures, conducted tests using MTS and Instron Machine and written reports for bioabsorbable products.

Utilized ISO 11737-2:2019, and ISO 11607-1 DuPont™ Tyvek® were used to subject the bioabsorbable product to the gamma radiation sterilization in nitrogen bed.

Label verification protocols drafted, conducted actual label verification testing and written technical reports on IFU, Primary Label and Secondary labels.

Prepared, submitted and negotiated with regulatory authorities to resolve questions/issues that arose during the product lifecycle and successfully obtained Premarket Notifications [510(k)s] approvals for Bioabsorbable Devices.

BECTON DICKINSON and COMPANY, Franklin Lakes, NJ 1999-2006

Product Evaluation Engineer

Responsible to define and document the testing input requirements for Insulin Autoinjectors, Blood Glucose Monitoring System (BGM) and Insulin Pump as required per FDA’s cGMP and by BD procedures.

Created standardized test procedures for Insulin Autoinjectors, Blood Glucose Monitoring System (BGM), Insulin Pump and Lancer Devices.

Prepared design verification matrix by incorporating international standard IEC 62366, originated protocols, designed test fixtures, and conducted actual tests on Blood Glucose Monitoring System (BGM) and Insulin Pump (IP).

Incorporated international standard IEC 60601 for basic safety and essential performance requirements of BGM and IP to ensure that no single electrical, mechanical or functional failure shall pose an unacceptable risk to patients and/or operators using HP oscilloscope.

Assisted in design and fabrication of life cycle testing equipment simulating human factor functions.

Support the Human Factors Engineering function in collaboration with project teams to ensure optimal usability characteristics and use safety of the Blood Glucose Monitoring System (BGM), Insulin Pump and Lancer Devices is accomplished and documented.

Participated in clinical trials on Human Factors Engineering and Usability into the Insulin Autoinjectors, Blood Glucose Monitoring System (BGM), Insulin Pump and Lancer Devices.

Analyzed and measured glucose in whole blood.

NORMED Medizin-Technik GmbH, 2002-2004

Regulatory Affair Consultant

Prepare, submit and successfully obtained Premarket Notifications [510(k)s] approvals for Normed hand and foot devices.

Review and approve product labeling and advertising.

Review change control documents for compliance with regulatory submissions requirements.

Coordinate and participate in routine FDA communications (including conference calls, written Correspondence and meetings).

Prepare regulatory assessments for new products and changes to existing products to determine the appropriate regulatory pathway to market.

Provide regulatory strategy, guidance and support as needed to Sales, Marketing, R&D, OEM, International, Engineering, Quality and Manufacturing.

Review and keep current with FDA regulatory requirements and trade publications.

Prepare written updates to management regarding status of regulatory tasks.

PFIZER-HOWMEDICA/ Stryker INC., Rutherford, NJ 1978-1999

Principal Research Engineer

Sole responsibility for evaluation of orthopedic products for introduction to market.

Created standardized test procedures for orthopedic devices (knee, hip, maxillofacial and trauma systems); several procedures were adopted as national standards by the American Society for Testing and Materials.

Designed resorbable polymers to meet specifications for degradation kinetics and weight loss over time in maxillofacial products.

Utilized composite materials, such as PEEK in design and development of hip stems and external fixtures.

Hired, trained and supervised staff engineers.

Supervised data analysis and testing procedures by staff engineers.

Designed hydraulic test equipment – saved over $1.5 million on equipment costs.

Consistently met tight deadlines and budgetary requirements.

Wrote/submitted technical reports to the FDA; gained 510K approval on all products.

Teamed with orthopedic designer-surgeons in surgically testing new orthopedic devices in cadavers.

Participated in post market surveillance of Howmedica orthopedic devices (knee, hip, maxillofacial and trauma systems) according to the FDA 522 Post market Surveillance Studies Program.

Supervised and analyzed data to identify the need to take any action and performed mechanical testing as needed.

thermal deposition process

SKILLS AND EXPERTISE

Profession in reviewing and verifying Solid Works and AutoCAD Design Documents

Six Sigma Black Belt and Lean Six Sigma Green Belt

AAMI Quality System Requirements and Industry Practice (with ISO 13485:2016)

AAMI Design Controls Requirements and Industry Practice, dFMEA, pFMEA

PATENTS AND PUBLICATIONS

Spine and Sport Medicine System

Journal of American Academic of Orthopedic Surgeons

(Articles on improved wear characteristics of knee replacement system)

PROFESSIONAL ASSOCIATIONS

American Society for Testing and Materials (ASTM)

Medical and Surgical Materials and Devices Subcommittee

American Institute of Chemical Engineering (AIChE)

American Society of Mechanical Engineering (ASME)

EDUCATION

MS, Mechanical Engineering, Fairleigh Dickinson University, Teaneck, New Jersey, 1979

BS, Chemical Engineering, New Jersey Institute of Technology, Newark, New Jersey, 1977

LANGUAGES

Proficient in Persian and Hebrew languages

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