EXECUTIVE SUMMARY

Results driven operations professional with expertise in establishing,

stabilizing and optimizing the supply chain and manufacturing for medical

devices. Proven track record of successfully leading manufacturing initiatives

for new product introductions to support commercial launches globally as well

as the deployment of sourcing strategies to mitigate supply chain risks.

Passionate about continuous improvement throughout the supply chain, the

importance of fostering supplier relationships and fact-based decision making.

Technically versed to manage product life cycle obstacles and proven leadership

in a cross-functional environment to meet objectives.

Contact Manufacturing Negotiation Strategies Manufacturing Agreements

Project Management Cross-Functional Teams Metrics Development

(KPIs)

Supplier Qualifications Supplier Development ASL Management

Make vs. Buy Analysis Manufacturing Transfers Strategic Sourcing

6-Sigma Black Belt GMP /QSR Audits FDA CFR Part 820, ISO

13485

PROFESSIONAL EXPERIENCE

INDEPENDENT CONSULTANT, GREATER BOSTON AREA 2013 - Present

Lead manufacturing and supply chain initiatives to support new product

introductions as well as sustaining product lines for the medical device

and pharmaceutical industries. Most recent responsibilities include

assessing operational capabilities for a key manufacturing process and

executing a robust factory acceptance test at supplier in Europe prior to

crating/shipping to client in U.S.

Medrobotics corporation, Raynham, ma 2011 - 2013

Manager, Contract Manufacturing: Responsible for the planning and

execution of development builds and commercial ramp up operations for the

new product introduction of a surgical robotic system consisting of

multiple system components ranging from complex capital equipment to

disposables

. Established and negotiated manufacturing agreements with key

suppliers and contract manufacturers. Developed supplier

relationships with key suppliers and lead manufacturing transfer

deliverables.

. Created, staffed and lead manufacturing engineering department to

ensure appropriate resources established to support the creation of

device master record documentation, execution of manufacturing

qualification plans and collaborated cross-functionally to implement

DFM/DFA methodologies into the design process.

. Established cross-functional teams to integrate operations into an

R&D centric environment. Established manufacturing readiness

requirements and key performance indicators to provide measurable

metrics to deliverables and aid in transforming culture to increased

accountability.

ranul inc., rockVILLE, md 2009 to 2011

Consultant / Global Operations Leader: Consultant responsible for

providing clients in the medical device industry with expertise and

leadership in advanced manufacturing and supply management to support on-

time commercialization of new products. The primary focus is on

identifying and implementing best in class practices for new product

introductions involving clients and external manufacturers. Clients

included Georgia Institute of Technology, Johnson & Johnson and Creganna-

Tactx Medical.

. Lead supply chain and manufacturing work stream groups to ensure

project deliverables met milestone commitments to support the global

launch of new medical devices with external manufacturers.

. Developed operations strategies to ensure manufacturing readiness

for design transfer phase.

. Revised distribution and manufacturing agreement terms as needed to

improve product life cycle management and supplier relationships.

. Performed manufacturing / supply chain due-diligence assessments to

evaluate supplier partnership potential. Performed GMP line audits

of external manufactures to evaluate and ensure product launch

readiness.

Hologic Inc., Marlborough, MA 2007 to 2009

Manager, Contract Manufacturing: Overall responsibility for worldwide

external operations and east coast manufacturing of the gynecological

surgical products division. Responsibilities included the management of

OEM/contract manufacturing, leading cross-functional operation teams to

support new product introductions and manage base business production

activities.

1. Initiated multi-sourcing strategies as well as supplier

consolidations to leverage supply base capabilities and improve

continuity of supply. Performed make vs. buy analyses for existing

products as well as new product introductions to determine in-house

manufacturing or external manufacturing.

2. Lead project team for the site to site transfer of manufacturing

from west coast to east coast operations while ensuring continuity

of supply was maintained. Managed the construction and

qualification of a new manufacturing site which included a

controlled environmental room to support manufacturing transfers.

3. Created a supplier selection and qualification process for the

global supply chain of surgical products. Trained US and OUS sites

for the implementation of process to reduce supply risks and improve

total value stream.

4. Generated RFQs, evaluated bids, provided recommendations based on

bids and created contract manufacturing agreements in collaboration

with legal council to meet operation goals.

Cordis, a Johnson & Johnson Company, Miami, FL 2001 to 2007

Senior Procurement Agent, Worldwide Strategic Sourcing (Feb-2004 to April

2007): Managed global spend for contract manufactured finished devices

and developed the strategic sourcing direction to improve continuity of

supply and spend productivity.

. Developed negotiation strategies and negotiated supply agreements to

improve quality and value of spend category. Negotiated a multi-year

supply agreement in 2006 which resulted in $2.5 million in savings as

well as terms and conditions to improve quality and supply continuity.

. Developed and executed plans to improve supplier relationship

management. Held quarterly business reviews with strategic suppliers

to communicate and align on business metrics such as cost, quality and

delivery as well as status on continuous improvement initiatives.

Established and improved relationships with executive management and

middle management of suppliers to foster a partnership mentality.

. Generated plans of purchases to provide a 5-year outlook on sub-

category spending based on market conditions, new technologies and

economical factors.

Senior Engineer / Project Leader, External Operations (Feb-2002 to Feb-

2004): Developed and executed manufacturing engineering projects to meet

operation goals and objectives. Managed technical relationships with OEM

contract manufacturers and suppliers and lead supply chain projects.

. Successfully completed the outsourcing of a guidewire portfolio from

internal manufacturing to contract manufacturers resulting in $2.4

million in cost savings. Project involved the management of multi-

company transfer teams through the use of project management knowledge

and risk management principals. Also provided technical support by

acting as lead manufacturing engineer.

. Improved product performance for core products to avoid loss of sales.

Fielded sales force complaints and performed on-site VOC (voice of

the customer) initiatives in hospitals with cardiologists. VOC

information filtered to identify potential engineering changes to

improve product performance through manufacturing process

improvements. One of the projects lead to salvaging a relationship

with a key account.

Manufacturing Engineer II, External Operations (Jan-2001 to Feb 2002):

Provided manufacturing support for OEM supplied products by executing

quality improvement initiatives through the use of process excellence

principles.

. Implemented process improvements using DMAIC principals for the

manufacturing of guidewires to improve rolled throughput yields

resulting in cost savings.

. Performed ROI analyses for potential process improvements to ensure

targets achieved before engineering execution.

MENTOR CORPORATION, IRVING, TX. 2000 to 2001

Manufacturing Engineer (Aug-2000 to Jan-2001): Provided engineering

support for manufacturing operations to reduce production costs and

improve product quality.

. Team leader of a multi-million dollar project to increase

manufacturing capabilities by 200% through facility expansions, the

integration of automated processes and SPC systems.

. Implemented lean manufacturing principles to improve process flows and

integrate ergonomic techniques into the redesign of manufacturing

equipment and tooling. Scrap rates and cycle times were reduces

resulting in an annual savings of over $125,000.

New Product Development/Process Engineer (Feb-2000 to Aug-2000): Support

the integration of new products from concept to manufacturing by

providing equipment, process and product validations.

. Improved equipment and process qualification documents to address FDA-

483 non-conformances.

. Performed process qualification activities to support the PMA approval

of a new product line.

. Lead CIT (Continuous Improvement Team) efforts to increase production

yields through cross-functional collaboration on defect rates, safety

issues, training and QC inspections.

Aksys Limited, LINCOLNSHIRE, IL 1995 to 2000

Engineering Manager (Oct-1997 to Jan-2000): Provided leadership for a

team of engineers and technicians tasked with the design, development and

qualification of complex subsystems for the new product introduction of a

hemodialysis machine for in-home use and daily modality.

. Supported IDE submission activities through subsystem validations,

microbiological studies, biocompatibility testing and FMEA/FMA

development.

. Lead a cross-functional team to measure and improve product

reliability utilizing MTBF techniques, pareto analyses and accelerated

life testing.

. Designed and developed high-level system diagnostics to address

subsystem calibrations and system burn-in requirements.

Senior Engineer (Oct-1996 to Oct-1997): Responsible for the design and

verification of critical subsystems.

. Developed subsystem and component capabilities using DOE techniques.

. Designed an ultrafiltration collection system to non-invasively

measure fluid levels and provide a feedback loop for peristaltic pump

calibrations.

Engineer (Oct-1995 to Oct-1996): Provide engineering support for new

product development activities.

. Created and executed protocols and reports to support design

verifications and validations.

. Designed and developed a negative feedback control system utilizing

infrared light to control blood flow rates to satisfy product safety

requirements.

. Assisted in the development of a pre-treatment system utilizing carbon

and particulate filters to ensure consistent water quality for

dialysate solution production.

EDUCATION / SKILLS

< Masters of Science, Engineering Management. Florida International

University

< Bachelors of Science, Bioengineering. University of Illinois at

Chicago

< CPM Certification, Institute for Supply Management

< Johnson & Johnson Process Excellence Black Belt Certification

< Cordis DMAIC Green Belt Certification

< ERP/MRP/PLM Systems: Oracle, JD Edwards, BPCS, QAD Mfg Pro, Ariba,

Agile [pic]

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