*.PROFESSIONAL CAREER SUMMARY

Project Engineering Professional with extensive experience from concepts to manufacturing, development and product launch. Support and maintain Quality Management System in compliance with the following standards and requirements: ISO9001; FDA’s Quality System Regulations 21CFR820; ISO 13485; ISO 14971

Key strengths include:

DHF improvements/remediation for legacy products.

MDR – new classification system, conformity assessment paths, Annex I requirements, technical documentation, CE marking, UDI, Clinical testing, Notified bodies

Design Control, Project Management, Material selection, Risk/hazards Management, Statistical tools, Q.A/Manufacturing/Sterilization/Regulatory interface, Alternate sourcing, Manufacturing Automation, Process & Equipment Validation (IQ, OQ, PQ & PV), Label Copy, New Business development, Clinical Studies support, Root Cause Analysis, CAPA projects, Gauge R&R

Broad experience in plastics processes (manufacturing, raw materials, piece part design) including films, and non-wovens and bonding techniques

PROFESSIONAL EXPERIENCE

Worked as a contract employee since 2009 for Medical Device Consulting Corp. Project management experience exceeds a span of 33 years in Medical Devices and Device Drug combination products.

INDEPENDANT CONSULTANT for Medical Device Consulting Corp. 2009 to present

Sr. DHF Improvement Engineer: (2014 – 2019)

Baxter Round Lake Il

DHF Improvement of legacy dialysis disposables manufactured in domestic and global locations

Documentation of User needs, Functional/Regulatory Requirements (design inputs), Verifications/validations (Design outputs), leveraging verification studies of similar worst case products to rationalize verifications, DOORS coordination, Design transfer of documentation, Risk Management and Human factors updates Trace Matrix, DHF Index, UDI compliance, Label copy updates

Sr. Engineer II:

AbbVie, North Chicago, IL

Drug Device Combination products (10/12 to 6/14)

DHF Remediation - Provided Design Control support to Humira and Androgel projects. Supported the generation of DHF documentation (Design development Plan, design input requirements, Design verification Plan, Risk Management). Provided input to Design Transfer Plans for TPMs and internal Manufacturing sites). Investigated impact assessment of design changes.

Coordinated with Third Party Manufacturers in providing technical support. Coordinated in the design development initiatives, and verification testing by TPMs and internal support groups. Reviewed the verification protocols and final reports. Supported in the resolution of variances.

Philips Healthcare, Franklin Park, IL (3/12 –8/ 12)

Operating Room Lighting Products (Class II)

Coordinated Production line transfer from Chatsworth, CA to Franklin Park, IL. Developed Master validation plan, Process & Equipment Validations (IQ/OQ/PQ) – Authored protocols, execution, statistical data review, & final report - SOP & Test Method development, and validation, Operators Training, Reg. Affairs Support (site & product registration) - Documentation support (DHF & MDR), Facilitated vendor approvals, Coordinated Product/Process risk analysis - Supported TUV and ISO13485 audits

Endoplus, Buffalo Grove, IL (9/ 11 – 2/12)

Laparoscopy Devices (Class II)

Design Control remediation, CAPA projects, facilitated internal audits, Coordinated FDA 483 responses, Product/Process Risk analysis, Provided Quality Guidance, Facilitated non-compliance projects, Label copy review and Packaging validations

IFANCA, Park Ridge, IL (6/ 10 – 9/ 11)

3rd Party Halal Certification

Food & Beverage, pharmaceutical, personal care, cosmetics and neutraceuticals

Halal certification based on ingredient/raw material analysis, Facilitated contractual agreements and manufacturing facility audits, & global export support, halal education, GMP/GLP, HACCP, Halal risk assurance, Allergens, Sanitation, Pest Control

Kay Medical, Grays Lake, IL (9/ 09 – 3/ 10)

Pharmacy medication transfer kit -

Product development of disposable for Baxa transfer pumps, Total documentation and quality support

Ediosmed, IL – (9/ 09 – 12/ 09)

Surgical Depth Gauge for Orthopedic surgery

Regulatory support for 510K submission, Design file for surgical depth gauge product, Developed Quality system per 21CFR 820 for off-shore contract manufacturer

CARDINAL HEALTH, Waukegan, IL 2001-2009

Sr. Project Engineer (Clinician Apparel and Personal Protection - $300 million) (2007 – 2009)

Innovative product/quality development of surgical gowns, surgical drapes, face masks and eye shields for Operating Room and lead resource for Green & Sustainability.

Supported the development activities (user fit & mask filter-media penetration) of Surgical Face Mask development (target market $18 million). Worked with suppliers to improve performance, implement process control and quality plans.

Project Specialist (Patient preoperative prepping products - $60 million) (2001 – 2007)

Lead quality/manufacturing support for skin prepping products and main supply chain contact for private label hair clipping products for Operating Room.

Managed the private label distribution of surgical clipper system for the preoperative hair removal of patients. Provided direction to the global partner in developing and launching a high margin disposable clipper blade product (projected $4 million). Increased market share for this product line to 49% - total market $47 million.

Transferred the manufacturing operations of patient skin scrubbing products from vendor-source to in-house manufacturing (validation of the assembly process, assembly-equipment and fixtures, and training of operators). Modified the documentation -Process Quality assurance specifications, Raw material inspection data sheets, Standard production methods, and visual standards) and coordinated the development and validation of sterilization, validation of packaging and distribution and development of DMR (device master record) for in-house produced product. Lead CAPA projects and coordinated field trials.

Project management of Injection molds transfer from vendor site, CA to IL and facilitated the Process capability of the molds for foot pump.

FENWAL HEALTHCARE (formerly Baxter Health Care – now Fresenius Kaby), Round Lake, IL 1993 - 2001

Engineering Specialist (Cellular Infection Prevention)

Responsible for the design & development of disposable kits for Apheresis blood components machine

Collaborated with joint developing partner in commercializing pathogen in-activation technology for platelets (market potential of $1 billion). Developed disposable kit that interacted with hardware for photochemical treatment process, launched in Europe.

Developed Validation Master Plans and Validation Project Plans

Designed, prepared, and executed ; Installation Qualifications (IQs), Operational Qualifications (OQs), Performance Qualifications (PQs) and Process Validations (PVs) for the cassette assembly

PRIOR PROFESSIONAL EXPERIENCE

KENDALL (TYCO) HEALTHCARE PRODUCTS CO., Mansfield, MA 1989 - 1993

Principal Engineer (Bladder Management & Anesthesia)

Production and quality maintenance of bladder management devices including cost reduction initiatives

Developed Urine meter ($2 million) to measure urinary output in surgical patients. Introduction of Urine Meter helped achieve # 2 market position for Kendall

Sustained $20 million business in bladder management (drainage bags, catheters, Foley trays, urine meters, and anesthesia trays). Optimized in-process and final release specifications that resulted in reducing the product quality reports by 15%.

HOLLISTER INCORPORATED, Libertyville, IL 1980– 1989

New Business Development Engineer

Identified and evaluated new business opportunities with marketable products that addressed unmet needs

BAXTER TRAVENOL LABS INC., Round Lake, IL 1976–1980

Principal Engineer (Intravenous Therapy kits and solutions)

Line extensions and product maintenance

EDUCATION

MBA, Management Roosevelt University

MS, Mechanical Illinois Institute of Technology

BS, Mechanical Engineering Osmania University

AWARDS AND HONORS

Recipient of Baxter Science and Technology Award for Amicus Component Design

Recipient of Baxter Fenwal Success Award for extra efforts to the FFP program

TA scholarship during graduate studies – Illinois Institute of Technology

Six Sigma Certified

Part time instructor at Harper College – Mechanical Engineering Subjects & Plastics workshops

ISSUED PATENTS

13 U.S Patents (7,105,093; 7,025,877; 6,902,335; 6,364,864; 5,425,717; D352,108; 5,322,512; 5,119,675; 4,889,534; 4,759,753; 4,610,677, 4,610,676; 4,411,659) & 7 US patent applications

PUBLICATIONS

oRespiratory Protection in the Healthcare Industry. Journal of the Association of Occupational Health Professionals in Healthcare, Spring 2009, VOL. XXIX, NO.2

oPoster session abstract " Novel Photochemical Treatment Kit" - AABB – 1999

oA Learning curve – Food Ingredients, Additives & Processing aides, Halal Consumer - 2011

CERTIFICATION / MEMBERSHIP

Licensed Professional Engineer

VOLUNTEER WORK SUMMARY

1.Al-Ihsan Sunday School Teacher Last 30 years

ISNS (Islamic Association of Northwest Suburbs)

Rolling Meadows, Il

2.Emergency Room Greeter 2014 to present

Good Shepherd Hospital, Barrington, IL

3.Patient Advanced Directive FOR Clinical Health 2016 to present

Decision Making

Good Shepherd Hospital, Barrington, IL

4.FaithBridge Executive Committee - Board Member 2019 to present

Faithbridge – consortium of faith based communities

in McHenry and Lake County

5.Grant Writer - UMMA (Urban Muslim Minority Alliance) 2019 to present

Waukegan Il 60085 (www.ummacenters.org)

6.Board Member – NIIMS 2020 to present

(Nagamia Institute of Islamic Medicine & Sciences)

Rolling Meadows, IL

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