DENNIS FERNANDES

**** ********* ******, #*** **** Beach Gardens, FL (Cell) 508-***-****

Email: acvgph@r.postjobfree.com

SUMMARY:

Supply Chain / Manufacturing professional with broad experience in all phases of technology manufacturing and operations. Specializing in medical device/ISO13485 environments to include, instrumentation manufacturing, project management, supply chain management and ERP systems implementation and support. Adaptable, hands on and excels in a rapidly developing environments with focus on startups.

APPLICATION EXPERIENCE:

Supply chain system development, critical supplier sourcing, evaluation and auditing.

ERP/MRP System implementation / system optimization, project management.

Contract manufacturing program development and management.

Lean Manufacturing, 5S, Continuous Improvement

cGMP, ISO-9001 & ISO-13485 implementation, support and ongoing compliance.

Business Process Flow, Value Stream Mapping (VISIO), & process/procedure documentation (SOP)

Inventory management, Kanban and cycle count system development.

Development of standard cost systems and cost reduction programs.

SYSTEM EXPERIENCE:

MS Dynamics Great Plains, Infor (SyteLine) ERP systems

Microsoft: Excel, Access, Word, MS Projects, VISIO Crystal Reports

PROFESSIONAL EXPERIENCE:

CAPTIVA SPINE, Jupiter, FL July 2013 – Present

Spine- medical device company focused on the design/distribution of spinal implants and surgical instrumentation.

Supply Chain Manager

Hired to develop the Supply Chain/Operations Groups personnel, processes and procedures to meet rapid 40% business expansion. As a member and facilitator of the senior management group:

Develop reliable / quality focused supplier base.

Move Asian to domestic manufacturing source (“onshoring”).

Evaluate and select new supplier / negotiating $2M annual blanket purchase of critical spinal implant source.

Develop instrument service department with trained personnel and improved processes.

Project lead on build out/relocation of 2 facilities to include inventory relocation. 2nd project completed in 5 weeks.

Member of the cross functional, design control team for new product launches.

Co Project Lead om ERP system implementation - Expandable

PRIMERA Dx, Mansfield, MA (acquired by Qiagen) July 2011 – Jan 2013

Medical device startup developing/commercializing molecular diagnostic instrumentation and supporting assays targeting pharmaceutical & cancer research and clinical lab diagnostics. (Business closed)

Operations Manager

Hired to develop the Operations/Manufacturing Group personnel, processes and procedures to meet cGMP & ISO-13485 requirements.

Hired/ trained supporting personnel (manufacturing/lab technicians).

Developed operating procedures (SOP’s) to support the implementation of ISO-13485 quality system. Achieved ISO 13485 certification in < 5 months.

Developed contract manufacturing sources of consumable products and manufacturing processes to improve product quality and build the supply chain.

Responsible for all facility and equipment maintenance. Developed equipment Preventative Maintenance (PM) program to meet cGMP & ISO-13485 requirements.

Responsible for supplier evaluation, development, quality to include site auditing.

Member of the corporate Cross-Functional Team consisting of: Marketing, Quality, Engineering, Assay Development and Operations.

CASMED MEDCAL SYSTEMS, Branford, CT 2008 -2011

FDA regulated medical device manufacturer specializing in vital signs monitoring (blood pressure & tissue oximetry.

Materials Manager

Hired to bring materials and inventory processes under control. Responsible for all inventory management & warehouse operations overseeing a group of 9 operators. Management of $8M of inventory in multiple locations (Branford CT, Jacksonville, FL. and overseas locations in the Dominican Republic and Puerto Rico).

Applied Lean manufacturing and 5S practices to improve warehouse operations through point of use inventory and application of Kanban replenishment methods.

Reduced lost inventory at “Vendor Managed Inventory” locations by approximately $200K through inventory sell off, site audit methodology, improved inventory control procedures and warehouse consolidation.

Improve inventory accuracy in the Jacksonville facility from 85% to 95% through the introduction of cycle counting programs.

Reduced obsolete inventory > $300K. Reduced non-conforming materials from > $200K through the development of processes.

ASSOCIATES OF CAPE COD Inc., Falmouth, MA

FDA regulated, biotech manufacturer focused on the manufacture of test reagents used in the detection of endotoxins for the Biomedical & Pharmaceutical industry.

Materials Manager 2005 - 2008

Responsible for the manufacturing supply chain to include hands on management of the Purchasing, Sales & Operations Planning, Forecast management, Production Planning functions and Warehousing Operations.

Redesigned warehouse operations to improve efficiency and compliance with cGMP & ISO 13485 standards to include development of SOP’s. Achieved ISO 13485 certification Sept. 06

Senior Materials Specialist 2003 -2005

Manufacturing team leader supporting the implementation of MS Great Plains, Manufacturing ERP system. Assist in the design of data conversion plan, provided end user training.

Design/Set up a standard cost system for entire product line. Configure bills of materials and process labor routings.

Implement product inventory tracking & forecast system to support weekly production plan.

Team leader/facilitator for Process Improvement Team. Design process flow diagrams utilizing VISIO to support continuous improvement program.

Validation Services Technician 2001 - 2003

Develop and execute equipment and process validation protocols using cGMP and FDA guidelines for commissioning of a new manufacturing facility.

TAQUA SYSTEMS, Hyannis, MA 2000 - 2001

Telecom startup, design and manufacture of class V switching systems. (Company went out of business)

Senior Materials Planner

Managed all sales forecasting analysis and master scheduling functions within Taqua.

The Operations Group specialist for companies ERP System (Baan), trained new users.

Designed/implemented a Master Scheduling business process, working with Operations, Sales and Marketing and Finance. Documented “Business Process Mapping” (VISIO) of all material flow through all processes in the manufacturing cycle.

COPLEY CONSULTING GROUP, Warwick, RI 1999 – 2000

Consulting organization focused in ERP system sales and implementation (Infor/SyteLine).

ERP/Manufacturing Systems Consultant

Team consultant on 3 projects. Project implementation included analysis of the company’s manufacturing/supply chain system requirements, training new users in a classroom environment in the areas of Purchasing, Engineering BOM’s, MRP and Inventory Control. Also assisted in data conversions and final “Go Live” conversions.

Project Leader on 1 of the project. Oversaw the project’s overall budget and time line (MS Project). Scheduled all project resources (other consultants assigned to the team). Developed custom program modification specifications

KARL STORZ ENDOSCOPY-AMERICA, INC., Charlton, MA 1998 – 1999

Logistics/Distribution division of Karl Storz Germany for all of North America. Manufacturer of endoscopes, surgical instruments and medical video products, etc.

Supply Chain Analyst

Successfully managed forecast, planning and purchasing of a broad range of medical devices manufactured in Karl Storz, German facility utilizing forecasting and logistics software.

Performed weekly forecasting analysis of 500 to 1,000 items. Placed weekly purchases of $200-$300K to meet the requirements of 500 daily shipments.

Assisted in the management of inventory of $20M through accurate forecast data management, obsolescence phase out and commodity management.

Working directly with sales and marketing group, planned materials for new product launches and product promotions.

FALMOUTH SCIENTIFIC, INC., Cataumet, MA 1995 – 1998

Startup, manufacturer of Oceanographic Instrumentation and Industrial Process Control Sensors. (Reason for leaving, business downturn, eventually sold).

Manufacturing Manager

Initially hired to implement appropriate changes to improve the Manufacturing/quality systems.

Direct supervision of Manufacturing Assembly, Quality Assurance, Purchasing, Production Control, Shipping and Receiving and Manufacturing Engineering.

Implemented quality systems, improved purchasing systems, critical vendor sourcing which includes specialized processes such as complex machined components, PC board assembly, injection molding and castings.

Oversight of all subcontract manufacturing suppliers

Responsible for final review of all manufacturing related costs for monthly closing to include variance analysis and material/labor standards

Implementation of Fourth Shift MRPII Manufacturing Software, completed in February, 1996.

BENTHOS, INC., North Falmouth, MA 1992 – 1995

Manufacturer of Underwater Acoustics and Imaging Systems, Robotic ROV’s (remotely operated vehicles) for the oil and nuclear industry and high speed, inspection systems for the packaging bottling industry

Materials Manager

Maintained the Master Schedule for multiple product line forecasts, manage a department of 8.

Coordinated all Purchasing, Inventory/Production Control, Shipping and Receiving functions.

Member of the Senior Management Group, formulated policies and long range planning for the corporation which included 3-5 year business plan and detailed, departmental budgeting

ISO-9001 Quality System Program Management. Certification to ISO-9001 completed in March 1995.

Oversaw all subcontract manufacturers to include negotiation of “turnkey” and “blanket” programs, supplier survey and evaluations for new product development programs

Member of R&D review teams, involved from concept, cost analysis, through production release stages.

EG&G MARINE INSTRUMENTS, Burlington, MA 1985 – 1991

(Company consolidation/relocation with Cataumet facility below). Manufactures environmental monitoring equipment and side scan sonar’s.

Materials Manager (1989 to 1991, Burlington, MA facility)

Supervised a department of 6, overseeing (and direct hands-on) all Material Planning, Master Scheduling, Production Control, Stockroom and Shipping and Receiving.

Team leader collaborating with consulting firm, during the implementation of a Just-In-Time program consisting of: design of “cell” manufacturing systems, inventory control systems move warehouse to “point-of-use”.

Team member of corporate-wide Total Quality management and Continuous Improvement program.

NEIL BROWN INSTRUMENT SYSTEMS, Cataumet, MA 1975 -1984

Startup scientific/oceanographic equipment design and manufacture (Company acquired by EG&G, see above)

Materials Manager (1982 to 1984)

oProject leader in implementation of ManMan MRPII system.

Manufacturing Manager (1978 to 1981)

Manufacturing Electronics Technician (1975 to 1977)

EDUCATION & AFFILIATIONS

BS, Lesley University, (Business & Management), 1984 - 1987

AS, Florida Institute of Technology, (Electronics Technology & Oceanography), 1973 – 1975

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