Program Manager/Engineering Manager

ANNE E. BUCHHOLZ ************@*******.***

Seven June Street 978-***-**** (H)

Pepperell, MA 01463 978-***-**** (C)

SUMMARY:

Accomplished, hands-on medical device professional with comprehensive large-scale management and engineering experience in a manufacturing environment. In-depth knowledge of program management, lean manufacturing principles, operations, quality systems and metric based goals and objectives in an FDA regulated manufacturing environment.

A Lean Six Sigma Green Belt with extensive training in Design of Experiments (DOE), Statistical Process Control (SPC), DMAIC Principles, Kaizen Events and Design for Manufacturability/Assembly (DFMA).

Outstanding communication talents with proven ability to build and lead highly efficient teams, to train and mentor technical personnel and to convey complex concepts in understandable terms. Performance-, process- and results-driven in commitment to quality and continuous improvement. Areas of expertise include:

•Program Management Product Development Process • Process Validation• Medical Device • Lean Manufacturing • Plastic Materials• Strategic & Tactical Planning Systems & Process Improvement • Capital Management

EXPERIENCE:

Accellent Inc. Wilmington, MA April 2010-April 2012

Accellent is a contract manufacturer that designs, develops, manufactures and assembles devices, implants and instruments for the cardiology, endoscopy, drug delivery, orthopaedic and general medicine markets.

Program Manager

Lead and manage cross-functional teams of engineers on multi-million dollar medical device development projects for major medical device OEM’s.

• Responsible for project management and execution, budget management and financial forecasting and key customer liaison from Concept Feasibility/Development (Phase 0-I) through Design Validation and Transfer to production (Phase III).

• Develop and execute detailed project plans to execute projects through the Product Development Process ensuring compliance with Quality Management Systems (QMS).

• Responsible for customer proposal development, contract negotiations, production piece pricing and all quoting /negotiating related to changes of scope.

• Manage and direct both internal and external suppliers to meet project milestones and pricing targets.

CREGANNA, Marlborough, MA Jan – Dec 2009

CREGANNA is a contract design and manufacturer of delivery and access devices for minimally invasive therapies. CREGANNA, MA provides a turnkey contract design and manufacturing service for specialty needle and catheter applications to medical device and lifescience companies.

Manufacturing Engineering Manager (2009)

Directed team of eight engineers accountable for process development, documentation, installation, training and qualification of new product pilot and production lines. Charged with operational support, continuous improvement efforts, automation, testing equipment, new product pilot and production tooling, equipment installation and qualification.

• Responsible for day-to-day production support, engineering project/task management, international project transfers and capital equipment acquisitions.

• Function as Program Manager for key customers coordinating all company activities including project management, customer interface, compensation for engineering services, piece part pricing and contract negotiations of new product launches.

ANNE E. BUCHHOLZ ************@*******.*** Page Two

• Direct process and equipment validation activities including Test Method Validation (TMV), Gage R & R, Process Capability, Installation Qualification (IQ), DOE, Operational Qualification (OQ) and Performance Qualification (PQ).

• Provide all budgetary capital expenditures for pilot / production tooling, equipment and automation for key customers and manufacturing site production scale-up.

NP MEDICAL INC., Clinton, MA. 2003 - 2009

NP Medical is an original design manufacturer of high performance fluid management components for medical device companies and a strategic company for Nypro Inc., a $1B global custom thermoplastic injection molding company.

Director of Process Development and Technology Transfer (2008 – 2009)

Charged with requirements definition, design, development, documentation, installation, training, qualification and transfer of new product tooling, automation and testing equipment to operations. Oversee product scale up, process optimization, technology transfer and process validation projects.

• Manage and direct team of four engineers to execute delivery of turnkey systems along with selection and management of external vendors. Built focused, cross-functional team, resulting in faster time to market for new products.

• Direct process validation activities including Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Design Qualification (DQ), Installation Qualification (IQ), Measurement Systems Analysis (MSA), DOE, Operational Qualification (OQ) and Performance Qualification (PQ).

• Conduct new material and process identification and validation, with alternate material validation (LSR vs. HCR) for existing product resulting in $1.2 M/year cost savings.

• Function as working manager for new product pilot and production tooling for thermoplastic and silicone tooling on new products. Supplier identification, assessment, downselection of new suppliers (micromolders, LIM moldmakers and LIM molders) outside scope of internal capabilities will allow for manufacturing of next generation products.

• Develop long-range tooling and automation strategies detailing supplier identification, selection, qualification and launch into production, resulting in clear, concise, up-front planning to execute production ramp-up on time and within budget.

• Provide all budgetary capital expenditures for pilot / production tooling and automation for design and development plan and to determine piece part pricing for new product contract negotiations.

Director of Engineering (2006 – 2008)

Directed team of eight engineers accountable for operational support, continuous improvement efforts, sustaining engineering for existing tooling, automation and testing equipment, new product pilot and production tooling, automation and test equipment, process development and new materials and processes.

• Successfully completed $6.9M capital expenditure request to purchase three high volume assembly machines and molds for replacement of antiquated equipment, reducing average cycle time of mold inventory and mitigating risk for capacity constraints. New automation resulted in improved product quality and increased production capacity.

• Program Manager for key customer (85% of sales), coordinating all company activities including new product launches, material validations and quarterly business reviews.

• Spearheaded team’s activities for largest customer for “first to market and new to world” product addressing critical concern of hospital infections. Successfully proposed, pursued and achieved compensation for engineering services resulting in $1M financial gain.

• Championed new antimicrobial technology investigation, identifying and contracting leading SMEs to conduct Environment Health Services (EHS) assessment to insure employee safety and mitigate business risks.

• Mentored teams, providing technical leadership and enhanced productivity by developing stronger perspective regarding personal development and business requirements. Stretch goals and mentoring resulted in promotion for four of group’s eight engineers.

Program Manager (2003 – 2006)

Planned and coordinated all activities of designated programs involving direct contact with customers, suppliers and outside manufacturing facilities. Activities included design, development and validation of molds, spare components, new products and new materials, ensuring procedures, validations and documentation were developed for Operations.

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• Program Manager for key customer (85% of sales) coordinating all company activities, including alternate silicone (LSR) material and mold development activities, replacement tooling activities, root cause investigations for customer complaints and Corrective Action Preventative Action (CAPA) closures.

• Provided all budgetary capital expenditures for pilot / production tooling and automation for design and development plans; determined piece part pricing for marketing efforts.

INJECTRONICS, INC., Clinton, MA. 1999 - 2003

Injectronics Corporation is a custom thermoplastic injection molding company manufacturing components and assemblies for medical devices, automotive and consumer products.

Program Manager/Manufacturing Engineer

Managed all aspects of projects related to the feasibility, acquisition and production capability of injection molds producing medical components, consumer products and automotive plastic components.

• As Lean Manufacturing Champion, implemented lean manufacturing work cell, eliminating significant manual labor and floor space usage and resulting in cost savings of $650K.

• Directed successful price negotiations, account and project management for 238 design changes affecting 22 injection molds on 2000 Dakota/Durango HVAC launch, resulting in significant financial gain.

FORD MOTOR COMPANY 1984 - 1990

Ford Motor Company is a Fortune 500 automaker.

MILAN PLASTICS PLANT, Milan, MI

A plastic products division of the Ford Motor Company.

Manufacturing Development Engineer, Advanced Manufacturing Engineering Group (1990)

Accountable for evaluation, improvement and development of existing and future manufacturing processes.

SALINE PLASTICS PLANT, SALINE, MI

A plastic products division of the Ford Motor Company.

Product Development Engineer/ Manufacturing Process Engineer, Molding Engineering Group (1985 - 1990)

• Managed all aspects of projects related to feasibility evaluation, acquisition and production capability of injection molds producing instrument panels and instrument panel components.

• Responsible for specification, procurement and installation of plastics processing equipment.

• Major projects included large press replacement project for twelve injection molding machines and establishment of injection molding machine preventative maintenance program for 144 machines.

Materials Engineer, Quality Engineering Group (1984 – 1985)

Accountable for quality of incoming raw materials, evaluation of new materials, maintenance and acquisition of laboratory equipment.

EDUCATION:

B.S.E., Chemical Engineering, University of Michigan, College of Engineering, Ann Arbor, MI

Graduate Courses, Polymer Science, University of Michigan, Rackham School of Graduate Studies, Ann Arbor, MI

AFFILIATIONS:

Elected North Middlesex Regional School District School Committee member – 1999 - present

TECHNICAL SKILLS:

• 8D/ Root Cause Analysis • ISO 9001 cGMP:21 CFR Parts 210, 211, 820

• Design of Experiments (DOE) • Statistical Process Control and Process Capability

• Failure Mode and Effects Analysis (FMEA) • ISO 13485

• QS-9000 • Process validation including IQ/OQ/PQ that meets QSR

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