Manager Engineering

MARIE E. ALLARD

** ******* ****** #*, ******, MA • Cell 508-***-**** • ***********@*****.***

SUMMARY OF QUALIFICATIONS

Results-oriented Senior Engineering Technician/Lab Manager with extensive experience within leading medical device companies, advancing product innovations from conception through commercialization. Emphasize cross-functional collaboration with suppliers and customers. Tackle complex and challenging tasks with efficiency. Actively support high performance team environments, allocation of resources, and fiscal requirements. Expertise in New Product Development (NPD):

PROFESSIONAL SKILLS

Lab Management • Product Verification & Validation

Process Evaluation • Vendor Management & Inventory Control

Design of Experiment • Quality Controls

Equipment Verification & Validation • Static and Dynamic Product Testing

Technical Troubleshooting • Acceptance Testing

3D Manufacturing • Wear Testing

Fourier Transform Infrared Spectroscopy (FTIR) • Failure Analysis

High Performance Liquid Chromatography (HPLC) • Gas Chromatography (GC)

Gel Permeation Chromatography (GPC) • Electric and servohydraulic test frames

PROFESSIONAL EXPERIENCE

June 2011 – 2018 Smith & Nephew, Inc. Mansfield, MA

A world leader in the development and commercialization of endoscopic techniques.

2013 - 2018: Lab Manager, Bio-Mechanical Testing and Analytical Testing Labs

Managed the Bio-mechanical Testing and Analytical Testing Laboratories for the Mansfield, MA facility. Completed major re-location of the entire lab facility to new location. Identified and acquired unique and state of the art equipment to support New Product Development (R&D) engineering efforts.

Confidently managed the overall operation of mechanical and analytical laboratories, including financial management, quality output, safety risk management, and facility management.

Drafted and designed new lab space, increasing capacity and visibility within the organization.

Routinely collaborated with department managers to correct problems and improve services.

Kept laboratories in compliance with all applicable FDA guidelines and laws.

Created and ensured adherence to SOPs for all equipment including training documents.

Performed lab tests and communicated results.

Introduced, negotiated, and implemented new resources to expand scope of laboratories.

Investigated, provided and submitted information to Quality Department about returns and CAPAs.

Participated in facility inspections made by authorized internal and governmental agencies.

Created and communicated new or revised policies.

Managed the maintenance and repair of laboratory equipment. Ensured instruments are working properly, scheduling preventative maintenance and working with technology support from various vendors to troubleshoot routine equipment issues.

2011 – 2013 Senior Lab Technician, Bio-mechanical Testing and Analytical Testing Labs

Assumed responsibility for all equipment calibration schedules, troubleshooting, and maintenance.

Managed the chemical and other supplies inventory as well as ensure laboratory compliance with appropriate standards.

Create and maintain a general laboratory environment that is characterized by operational excellence and adherence to highest safety standards.

Accurately recorded and reported test results according to established procedures.

Ensured adherence to safe work practices and procedures.

Trained technicians to operate lab equipment such as electro-mechanical and hydraulic test frames, metallurgical equipment, and analytical (chromatography) test equipment.

Assisted in troubleshooting product returns and after-sales support to ensure customer satisfaction.

Performed data analysis and provided recommendations to achieve adherence to product design inputs.

Assisted in engineering projects for validation and verification in accordance with FDA guidelines.

Prepared plans and layouts for equipment or system arrangements and space allocation.

Saved 5% on maintenance costs by working closely with suppliers while ensuring quality standards.

Assisted Engineering teams in test creation, fixture creation, execution, and reported findings.

Managed engineering changes using SAP system.

1994 - April 2011 DePuy Spine, a Johnson and Johnson Company Raynham, MA

$1 B spinal device company.

Senior Model Maker/Lab Manager, Engineering Services Group (2003 - 2011)

Senior Engineering Technician, Core Business Development, Codman (12/97 - 2003)

Engineering Technician, Polywear Group, Applied Research (10/94 - 12/97)

2003 - April 2011: Lab Manager, Prototyping Lab

Managed the Rapid Prototyping (RP) Laboratory for the Raynham, MA facility.

Identified and acquired unique and state of the art 3D additive manufacturing technologies, both in metal and plastic producing technologies. Executed significant process, quality, and turnaround time improvements.

Acquisition of equipment resulted in considerable savings of financial expenditures and time to market in product development cycles.

Achieved 10 – 20% growth in lab output each year.

Co-created and introduced web based ordering system on a WW scale, allowing the entire J&J network to order and track the process of Rapid Prototype orders regardless of location around the globe. Instituting the system established the Raynham facility as a Best in Class facility.

12/97 - 2003: Bactiseal® Antimicrobial Impregnated Catheter System project team.

A first of its kind hydrocephalic shunt system successfully impregnated with two different antibiotics throughout its silicone matrix, slowly and uniformly releasing them to all surfaces, including the inner lumens of the catheter system. A manufacturing process that is impossible to duplicate by any prophylactic method. Product line today is equal to approx. $.5 b in sales annually.

10/94 -12/98: P.F.C. SIGMA™ project team.

Modular knee system designed to improve wear characteristics by cross linking polyethylene. Complete change in sterilization technique. Results of this cross functional team, earned three team members the Johnson & Johnson Medal (highest scientific award). Product line was equal to approx. $1 b in sales annually.

PRESENTATIONS AND PUBLICATIONS

Comparison of metal-on-polyethylene and metal-on-metal hip components using two different joint simulators. M.B. Schmidt, and M. Lunn (Allard) Transactions of the Orthopaedic Research Society, 23:421.

Presented to a corporate level gathering on Codman, the company, as well as the Rapid Prototyping endeavors and future direction of such efforts at the Solid Freeform Symposium held at Ethicon Endosurgery, OH.

The results of my work have been acknowledged in several other publications and presentations, as well as having direct impact on FDA submissions such as IDEs, PMAs, and 510Ks.

EDUCATION

Roger Williams College – mathematical classes • Consortium continuing education

The Harris Hip Course • Blood Born Pathogens

Instron, 3D Systems, MTS Operator Training • Sales Training

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