R&D / Design Control Work-stream Lead
Clinical Innovations / – Consulting
FDA Compliance / Quality Systems / Research and Development / Operations
- Lead team to address audit findings in the areas of risk management, essential requirements checklist concerns, and material changes in a timely manner.
- Created and implemented new design control phases and deliverables in accordance with current MDD expectations and EU MDR.
- Leading and integrating project initialization, concept generation, and design control with Product Realization and Development System.
Medical Device Quality, NPD Engineer – Combination Products, Consultant
Regeneron Pharmaceuticals, Consulting, FDA and EU regulated industry / Combination Pharmaceutical Device
- Developed a gSPR checklist general safety and performance regulations (gSPRs), educated team on MDD to EU MDR transition for combination products.
- Outlined product realization process (from drug formulation through working with external partners and CMOs) in order to perform a gap assessment concerning combination product development including drug and device development, and the integration of future in-house filling capabilities.
CAPA COACH / DHF Remediation
Consultant – COOK Medical, Consulting FDA regulated industry / Medical Device
- CAPA COACH working to resolve Class III Central Venous Catheter product and process issues (such as the Regulatory decision process of when to submit a 510k for a change to an existing device).
- DHF remediation ensuring compliance to 14971 and understanding the required changes in transitioning from MDD to EU MDR (Regulation EU 2017/745); utilized post market hazard analysis (based on PMS) in conjunction with clinical effects analysis as inputs into the risk management process; HHA (health hazard analysis).
Staff Systems Engineer / Research and Development
Johnson and Johnson Ortho Clinical – Pharmaceutical/Clinical Chemistry/transfusion medicine
- Lead verification activities for IVD clinical chemistry micro-slide incubator and reagent handling subsystem. Created and developed new tests ensure the proper positioning of the rotor in relation to the to the reflectometer and micro slide.
- Lead external partner (located in Switzerland) in New Product Development (NPD) of all automated immunohematology analyzer subsystem teams (barcode reading, blood sample handling, agglutination card assessment, incubator, centrifuge, and agglutination card transport between subsystems).
Independent Consultant to Corporate Unit Quality / Research and Development
Becton Dickinson - BD is a global medical technology company
- Performed HHA (health hazard analysis). Resolved $1.1M issue of on-hold parts using my collaborative team leadership approach and concurrent engineering experience to efficiently conduct a risk investigation.
March 2019 – present
R&D Work-stream Lead Clinical Innovations / Consulting
FDA Compliance / Quality Systems / Research and Development / Operations
- Promoted from initial role as CAPA R&D consultant. Leading and integrating project initialization, concept generation, and design control with Product Realization and Development System. Leading a high performing R&D team and working with cross functional team members to evaluate and integrate existing products and their supporting design documentation into the quality system. Aligning R&D, regulatory (EU MDR / FDA), and quality systems while maintaining product and business continuity.
Apr. 2018 – Jan 2019
Medical Device Quality, NPD Engineer – Combination Products
Regeneron Pharmaceuticals / Tarrytown, NY – Consulting FDA Compliance / Quality Systems / Research and Development / Operations
- Provide technical and quality (especially design control guidance) leadership and support for class II electromechanical parenteral drug delivery device.
- Support combination product development efforts throughout clinical development, product registration, and commercialization. Work with internal and external partners, on efforts such as design inputs, quality planning, risk management, design verification and validation testing, design transfer, and design changes.
- Conversion from essential principles to general safety and performance regulations (gSPRs), MDD to MDR transition, FDA 21 CFR requirements and international standards (ISO, AAMI, ANSI).
- Outlined and executed a process map to describe the realization process for the delivery of combination product from concept to launch. Worked with various contributors including drug formulation group, combination product development, manufacturing, chemistry manufacturing controls (cmc), regulatory, and operations. Gained an understanding of the inputs and outputs between concept and launch to identify the gaps that would need to be addressed in order to accommodate in-house filling capabilities.
Oct. 2016 – April 2018
CAPA COACH / DHF Remediation
Cook Medical FDA Compliance / Quality Systems / Research and Development / Operations
- Executed the CAPA process to resolved Central Venous Catheter product and process issues (such as the Regulatory decision process of when to submit a 510k for a change to an existing device).
- Worked with cross-functional teams. I efficiently determined root cause and performed verification and validation of preventive actions. Reviewed DFMEA/PFMEA/UFMEA.
- The normal course of CAPA related work required me to perform (as needed) root cause analysis, design of experiments (DOE), Gage R&R, and statistical analysis in accordance with FDA guidelines 21 CFR 820, QSR ISO 13485, ISO 14971 and cGMP.
- Executed DHF remediation. Redefined medical device families as needed. Created complaint (PMS) traceability documents such as PMHA, CEA (clinical effects assessment), regulatory trace tables, targeted design/process trace tables, and targeted assessment summaries.
- Experience aligning customer requirements with product specifications through hands on interaction with R&D and manufacturing.
Aug. 2010 – Aug. 2016
Staff Systems Engineer / Research and Development
Johnson & Johnson Ortho Clinical Diagnostics / Rochester, NY
- Lead Systems Integration and Product Development teams in the areas of Verification and validation of automated (electromechanical) clinical chemistry, immunohematology systems, and extracorporeal photopheresis machines - Class II Medical Devices. Team Leader for Therakos division system investigations. Developed test methods and verification plans. Risk based sample size determination for Verification and Validation execution.
- Lead systems project team investigations and provided a structured approach to problem solving using my ASQ Black Belt skills. Lead CAPA (corrective action preventive action) investigations identified in the DTR (defect tracking record) system. Resolved DTRs triggered by field engineers' observations, customer complaints, and product design challenges.
- Experience Leading product development teams involved with third party design and build of electro-mechanical subsystems as well as their interaction with software technologies. Worked with reliability teams to understand and improve Mean Time Between Failure (MTBF) performance of various subsystems.
- Subject matter expert for Design of experiment (DOE), Sample size determination and justification towards the support of technical files within the DHF structure. Performed root cause analysis, design of experiments (DOE), Gage R&R, and statistical analysis in accordance with FDA guidelines 21 CFR 820, QSR ISO 13485, ISO 14971 and cGMP.
- Facilitated FMEAs using DFSS methods by implementing tools such as boundary and parameter diagrams. Developed knowledge in the rheology of blood to resolve challenges.
- Developed, executed, and summarized verification test methods and plans including statistically based sample size recommendations necessary to provide objective evidence in accordance with product requirements documentation. Guided technicians and operators in the execution of experimental tasks. Traveled to Switzerland - guided Swiss engineers in best practices for new product design.
- Skills: Systems Engineering, Medical Device product and equipment Validations (IQ, OQ, PQ), MINITAB and Statistical Analysis, Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), Root Cause Analysis, DMAIC (Six Sigma), cGMP, FDA guidelines, CAPA, CAR
Feb. 2010 – Aug. 2010
Industry Consultant to Corporate Unit Quality / Research and Development
Becton Dickinson / Franklin Lakes, NJ
- Consultant to corporate unit quality team and R&D Hypodermic core team – Class II Medical Devices. Lead senior quality engineer for quality issues coming out of Brazil and other facilities around the world. Facilitating design and process failure modes and effect analysis (FMEAs) as well as design and end-user risk assessment.
- Managed the risk of releasing non conforming cannula that was cut using a dull blade. Created health hazards analysis report (defined affected lots and scope, quarantined affected product at distribution centers). Obtained cross functional input from operations, medical affairs, and R&D.
- Responsible to review validations, design controls for worldwide facilities, using my mechanical engineering background and statistical analysis to aid in decision making and justification in accordance with FDA guidelines 21 CFR 820, QSR ISO 13485, ISO 14971 and cGMP.
Nov. 2009 – Feb. 2010
Industry Consultant to Operations/Continuous Improvement
Stryker Orthopedics / Mahwah, NJ
- Provide non-conformance and corrective action preventive action resolution support to operations team in accordance with 21 CFR 820 and ISO 13485 guidelines.
Sept. 2007 – Jan. 2009
Lead Mechanical Design Engineer /ASQ Black Belt
FujiFilm, DIMATIX / Lebanon, NH
- Lead concept design efforts MEMS piezoelectric ink jet jetting assemblies – gathered cross functional teams including suppliers to guide designs through phases and gates process from concept through manufacturing.
- Responsible for the design of MEMS piezoelectric ink jet jetting assemblies including internal system such as thermal, fluidic, electronic, and mechanical subsystems.
- Worked with and guided reliability engineers for statistical sample size and test designs to understand mean time between failures (MTBF) for critical components.
- Skills: Design Engineering, Solid Works 2008, Advanced GD&T, MINITAB and Statistical Analysis, Design of Experiments (DOE), Design for Six Sigma (DFSS), Failure Mode and Effects Analysis (FMEA), Quality Function Deployment (QFD), KANO model, P-Diagrams, System-boundary diagrams.
Dec. 2004 – Sept. 2007
Quality Engineering Manager, Six Sigma Black Belt (ASQ)
Pall Corporation, Medical / Biopharmaceuticals, East Hills, NY
- Lead quality engineering and validations of new and existing medical device products including Tangential Fluid Flow Cassettes, Blood filters, IV Systems, Bio-Tech Pallsep, and Nylon pleated filters. Established quality systems from feasibility through manufacturing and production for filters using pharmaceutical grade plastics.
- Lead CAPA/non-conformance investigations – developing and implementing corrective action preventive action plans supported by providing statistically sound objective evidence.
- Created a flow of the CAPA/non-conformance process to visually understand its efficiency and effectiveness in order to seek out opportunities for improvement.
- Improved the quality system at various facilities by base-lining existing quality systems and working with the plant manager and staff to streamline and add or modify quality checks through the manufacturing process.
- Performed root cause analysis for blood and pharmaceutical filter production challenges at various manufacturing facilities around the world. Timely resolution was required, and I typically put a verified solution into place within 30 days of project start.
- Resolved a historical production issue with a tangential fluid flow cassette product line where I implemented an improved interleaving material that minimized damage to the membrane as it was processed through the plant.
- Trained facility engineers (Tijuana, California, Puerto Rico, England and New York) on DMAIC methods and trend analysis.
- Skills: Quality Engineering, Medical Device product and equipment Validations (IQ, OQ, PQ), MINITAB and Statistical Analysis, Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), Root Cause Analysis, DMAIC (Six Sigma), cGMP, FDA guidelines, CAPA, CAR
Jun.2000 – Jul. 2004
Lead Senior Mechanical Engineer (SSBI clearance status inactive) - Precision Optics
Eastman Kodak Company, Commercial & Government Systems, Rochester, NY
- Lead all abrasive water jet cutting and rough grinding and polishing operations activities of the division - utilized top down and bottom up error budgeting to achieve project goals.
- Responsible implement and review rough grinding and shaping operations corrective actions and lessons learned database.
- Developed thin-walled (0.457mm) glass core cutting capability (originally a 3.175mm process) for multiple 1.4-meter mirror segments based upon a hexagonal core structure design using a CNC abrasive water jet. Designed small scale prototypes to define and improve critical functional responses. Created manufacturing and equipment readiness tests to ensure the likelihood of providing multiple good products and fulfilling the customer requirements.
- Skills: Aerospace, Process Engineering, Project Management, Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), Root Cause Analysis, Lean Six Sigma, Job Hazard Analysis (JHA), CNC/PLC, CAPA, Fault Tree Analysis, Unigraphics, MasterCAM.
Sept.1997 – Jun.2000
Senior Mechanical Engineer - Materials Technology Division Engineering (Aerospace)
Corning Incorporated, Materials Technologies Division, Corning, NY
- Improved the Low Temperature Fusion Mirror assembly process reliability by 25% by designing new and modifying existing equipment for a ($4MM project).
- Increased equipment utilization from 25%-75% via Kaizen. Designed process fixtures and specified waste handling equipment for production ready capability ($1MM savings).
- Ensured that the customer expectations and requirements were adhered to during fused silica product development by highlighting candidate glass run parameters that consistently met the customer requirements and determining process capability. Once a capable, reliable and repeatable glass run parameters was locked, I was responsible to create standard operating procedures, specifications, and production planning to deliver the development glass to the customer on time.
- Skills: Project Management, Design Engineering, Process Engineering.
Senior Product Development Engineer - Semiconductor Materials Commercial Business
- Lead new product development – interacting with the customer, R&D, Manufacturing, senior management and sales in order to qualify the next generation fused silica ARF glass.
- Utilized Stage Gate and Six Sigma Black Belt champion principles to assess & communicate the manufacturing process control and capability of 193nm ARF fused silica resulting in delivery ($1.3MM) of qualified prototype product to customers in U.S., Japan, and Germany.
- Wrote product processing procedures and specifications for production of development glass at the manufacturing facility. Reviewed and approved corrective action reports.
- Skills: Product Development, Project Management, Statistical Analysis, Quality Engineering, Process Engineering.
Sept.1995 – Sept.1997
Structural Analysis Engineer - Product Engineering/ Advanced Process Technology
Bausch & Lomb, Ray-Ban Eyewear Division, Rochester, NY
- Used Finite Element Analysis and designed verification equipment to resolve formed and molded product reliability issues by increasing the robustness of existing and future designs.
- Implemented corrective action and best practice strategy based upon verified solutions to manufacturing, design, and product engineering.
- Implemented project management in an FDA regulated environment, KT analysis, TOPS, and Gemba to integrate FEA with PDMP process for improved metal and plastic injection molded product resulting in $50K- $300k savings.
- Participated in cross function teams including Marketing, Research and Development, Product Engineering, Prototyping, Design, and Quality and as a team we developed VOC surveys to assess the needs of the customer against future product designs.
- Skills: Project Management, Design Engineering, Process Engineering, CAD and Finite Element Analysis including: Pro/Mechanica, NASTRAN, ANSYS, Uni-graphics and Pro/Engineer.
Aug.1992 – Sept.1995
Manager, Computer Modeling/ National Fenestration Ratings Council Certified Simulator
ETC Laboratories, Rochester, NY
- Utilized FEA to simulate the thermal performance of window and door products.
- Generated leading cash flow for the company consistently using TQM principles.
- Instructed Window manufacturer engineers on Department of Energy Ratings program for window and door products.
- Established the department guidelines, procedures and conformance to ISO 9001 and ISO 9000 standards.
- Skills: Management, Sales, Design Engineering, Project Management
Education: B.S. Mechanical Engineering, University of Rochester, 1992.
Publication: Semi-rigid active mirror technology advancements [4451-6] Optical Manufacturing and Testing IV, Matthews, Gary; Carbone, Frank A.; Clark, Patrick; Mack, Devin M.
Awards: Urban League and New York State Regents Scholarships; Brooklyn Technical High School Lenfest Award for Excellence in Mechanical Engineering
Appointments: Commercial Imaging Group Diversity Council, Eastman Kodak Company, Rochester, NY.
- Managed creation, implementation and continuous monitoring of quality systems improvements.
- Technical manager abrasive water jet for Dynamic Lightweight Mirror (DLM) program.
- Managed facilities and abrasive water jet process capital improvements.
- Lead technology transfer of abrasive water jet pocket milling technology from vendor to Kodak.
- Lead a team of 50+ people in order to qualify ARF fused Silica glass primarily at Canon, Nikon, and Carl Zeiss during my role at Corning Incorporated.
- Supervised up to 5 people throughout my career including dotted line and direct supervision of technicians and operators.
- Served as Backup to Quality Director at the Pall Corporation Hauppauge facility in absence of a QA manager – supervision for 16 Quality Assurance technicians and 4 quality engineers.