Operations Management Consultant: Vendor Qualification, Precision Manufacturing and Medical Device Fabrication

Expertise

• Diversified experience and demonstrated leadership in process development, engineering/project/program management of implantable, disposable medical devices and instruments.
• Experienced in converting pilot and research and development concepts to commercial scale high volume production.
• Expertise in process capability improvement, lean manufacturing and GMP in highly regulated environment such as medical device manufacturing.

Competencies

Medical device design, development and project management

• Transverse connector for inter-laminal spinal fixation system.
• Inter-vertebral spinal fixation body and screws.
• Cardiovascular devices and delivery system.
• Endoscopic devices, arthroscopic cutters, surgical staplers.
• Sliding mechanism and support structure.

Supply Chain Development

• Fabrication, machining, surface finishing, coating, laser welding and electromechanical assembly.
• Metal, plastic, electrical components and sub - assemblies.
• Cleaning, sterilizing, packaging.
• Metal hardening, burring and heat treatment.
• Mechanical, electrical and biological testing; manufacturing and test equipment, calibration.
• Purchase of raw materials (metal, plastics, chemicals, and packaging components).

Manufacturing Processes

• Precision manufacturing CNC, Swiss, lathe, milling, grinding, laser cutting and laser welding.
• Metal fabrication, injection molding, welding, surface finishing, coating, bio cleansing, sterilization and packaging.
• Electromechanical assembling.
• Medical device testing and labeling.

Regulatory and Quality Systems

• Design and developed under following medical device standard: ISO 9000 / ISO 13485; 21 CFR Part 820 - QSR, GMP; 510(K), regulatory approvals; QS 9000, ISO 14971 Risk Analysis.

Operations Management

• Purchasing and vendor management.
• Process and manufacturing engineering.
• Compliance, validation and maintenance.
• Tooling for design, development and production; tooling design modification.
• Investment planning, budgeting and equipment selection.
• Safety and work place regulations and employee development.
• Design and Material Review Board.

Experience

Undisclosed Company, Engineering Manager, 2008 - Present

• Managed research and development and manufacturing engineering for diversified contract manufacturing and development of specialized medical devices processes and company IP's.
• Established medical devices licensing agreement with business partners.
• Project managed cross-functional teams for development commercialized manufacturing processes for surgical markets including cardiovascular, CRM, and orthopedic applications.
• Implemented process excellence in manufacturing and business utilizing lean manufacturing and six-sigma methodologies.
• Validated vertically integrated complex manufacturing processes and obtained registration with regulatory agencies.
• Develop and executed strategic plan for corporate growth and identified critical technical capabilities, acquire and trained adequate resources.
• Supervised 13 engineering and technical resources in area of research and development, process engineering, lean manufacturing, metallurgical and mechanical testing.

Accellent, Inc., Collegeville, PA. and Watertown, CT., Group Engineering Manager 2005 - 2008

• Medical device design, development and manufacturing company, with revenue of $500 million.
• Supervised new product development, metallurgical testing laboratory, lean process excellence, and engineering data management groups. (Supervised 9 Engineers, 16 total resources at two sites).
• Developed multiple commercial scale production processes for company IP's and other medical devices.
• Prepared project plans, capital appropriation, project management through process validation involving multiple sites.
• Ensured proper allocation of resources to achieve project goals within established timelines and budgets. Monitored progress and reported status to executive management team.
• Managed a cross functional team on current and next generation stent development and related cardiovascular tubing applications.
• Interacted with customers, quality, operations, regulatory, marketing, and financial personnel to develop new and improve existing endoscopic and cardiac devices.
• Identified, evaluated, planned and executed improvements to existing and/or new products, processes, equipment, and technology utilizing lean manufacturing and six sigma methodologies.

Promed Staffing, Germany and U.S., Program Manager, 2003 - 2004

• Managed product development of human (allograft) and animal (Xenograft) implantable tissue product for orthopedic and dental applications.
• Developed Protocols for donor selection and tissue processing, transferred and validated manufacturing process from Germany to U.S. and obtain regulatory approval for production and market in USA.

Microcision LLC., Philadelphia, PA, Program Manager, 1999 - 2003

• Program managed design, development and project management of medical devices (Transverse connector for inter-laminal spinal fixation system, inter-vertebral spinal fixation body and screws, dental abutment, coping, drills, adapters) from market evaluation, design controls, development, approval, production launch to market release.
• Interacted with key customers on design decisions, technical design and development reviews, and suggested strategies with research and development marketing, and manufacturing communities.
• Developed and integrate technologies into next generation implant platforms.
• Prepared and executed strategic and tactical plans for business growth, contract negotiations, technology acquisition and resource planning.
• Supervised customer service, production, engineering services, finance, and human resources.
• Approved, developed and audited key suppliers and integrated other resources.
• Developed and executed validation protocols for design, processes, equipment and facility.
• Implemented ISO13485, QSR and GMPs and institutionalized SOPs.

Johnson Controls Inc., Dayton, NJ, Materials Manager, 1996 - 1999

• Premier supplier of auto interiors a $12 billion company with site revenue of $120 million.
• Supply chain and materials management of JIT Auto seats and interior plant for GM and Ford motor companies.
• Cross-functional project management for multi-plant concurrent engineering, ECN implementations, new product development and launch, process improvement, and cost reductions.
• Implemented lean / sigma projects, capability analysis, Kaizen, FMEA, control plans, CAPA and benchmarks to attain key initiatives, measurable and customer satisfaction.

Johnathan Manufacturing Co., Fullerton CA and Mexicali, Mexico, Lead Engineer, 1991 - 1996

• Design, development, and manufacturer of sliding mechanism and support structures.
• Led design group charged with development of product concepts and improvements including design modeling and drawings, management of the documentation process, management of vendor relationships and activity, procurement of component prototypes, and overseeing design transfer for production of steel and aluminum sliding mechanism for commercial, industrial, IT, and DoD applications.
• Managed global product launches, planned product phase out, product support and maintenance.
• Designed, created solid models and detailed drawings and maintain design control documentation and project files, developed and perform product testing, finite element analysis and reliability testing.
• Worked in a team environment and provided leadership within a cross-functional project team, moderated meetings, incorporated decisions into design concepts, developed evaluation protocols.
• Developed project plans included resource allocation, appropriate testing and analysis protocols, effectively transferred designs to manufacturing vendors and controlled design changes through the manufacturing process.

Honors & Publications

Credentials

• Six Sigma DMAIC Black Belt
• Lean Manufacturing - Certified trainer
• Demand Flow Technology (JcIT)
• Advance GMP, QSR, Process Validation

Design Tools and Software:

• Phase-Gate product design / development
• MS Office (PowerPoint, Excel, MS Project etc.)
• DMAIC Minitab
• CATIA / Solid works
• New Product Development (NPD) tools

Education

• M.S. Operations and Engineering Management, New Jersey Institute of Technology
• B.S. Mechanical Engineering, NED University of Engineering & Technology, Karachi