Damian Lew

Responsible for leading process improvement initiatives for medical device manufacturing operations, processes, and products for both internal company programs and contract manufacturing.

Responsible for the successful and timely completion of Design Development and Design Transfer projects for medical devices and drug combination products.

Responsible for the creation and implementation of standard operating procedures to improve operational efficiency and productivity.  

Specialties: Six-Sigma / Lean Manufacturing Expert (Black Belt Certification)

SHL Medical, Deerfield Beach, FL 33442; June 2021 to Present

Project Manager

Responsible for the successful and timely completion of Design Development and Design Transfer projects for auto-injector medical devices and drug combination products. Responsibilities include managing all aspects of project deliverables including phase planning, cost budgeting, resource allocation and risk management.  Requires working knowledge of international standards and requirements for medical devices.

• Lead cross-functional teams from project initiation through entire design control process to commercial launch
• Directly interface with customers and internal stakeholders to ensure product requirements and deliverables are met
• Manage projects qualifying a variety of manufacturing processes including injection molding of plastics, machining and testing methods, and automated assembly
• Coordinate internal resources and third-party vendors for timely execution of validation activities for contract manufacturing projects

Independent Contractor, Miramar, FL 33025, March 2020 to June 2021

Director of Operations

Responsible for managing company's resources, developing and implementing operational plan, and ensuring efficient and proper execution of procedures and daily operations for contract manufacturing project.  As Director of Operations, functions include:

• Maximized efficiency through extensive process analysis and setting strategic goals for increased productivity
• Built organizational operations team, and ensured key roles filled for production efficiency
• Removed obstacles and assessed company system improvements to streamline operational execution
• Managed and maintained department and project budgets including resource planning
• Interfaced with client and coordinated activities with department managers

Steripack Contract Manufacturing, Lakeland, FL 33811; December 2018 to March 2020

Senior Project Manager

Responsible for managing and coordinating the development, validation, and implementation of manufacturing projects for medical device clients.  Projects include developing processes such as ultrasonic cleaning, assembly, heat-seal packaging, form-fill-seal packaging, and new manufacturing processes as required by projects.  Duties included the following:

• Developed transit, shelf life, accelerated aging, and sterilization validation studies for medical device sterile barrier systems using working knowledge of guiding international standards i.e., ISO 11607, ASTM D4169, ASTM F1980
• Defined and managed project tasks, timelines, and milestones
• Determined and implemented solutions to challenges that may affect timelines
• Investigated and designated technological resources, materials, and suppliers that facilitate meeting project goals
• Analyzed, managed, and maintained project budgets
• Liaised between team members, department managers, suppliers, and service providers to coordinate and to complete project goals

Bovie Medical Corporation, Clearwater, FL 33760; November 2014 to December 2018

Senior Manufacturing Engineer

Responsible for the development and optimization of medical device manufacturing processes utilizing Lean-Six Sigma techniques

• Managed skilled cross-functional teams as Project Manager for implementation of process improvement efforts
• Led optimization projects of assembly workflows, space efficiency, and manufacturing equipment layout
• Troubleshot new or existing product problems involving designs, materials, and processes
• Reviewed and assessed product designs for manufacturability and completeness
• Executed root cause analyses/risk assessments for CAPA’s and non-conformances, and determined corrective/preventive actions

Dentsply Raintree Essix, Sarasota, Florida; February 2014 to October 2014

Quality Engineer

Responsible for directly supporting overall validation and quality improvement initiatives for secondary manufacturing processing of metal injection molded components and assemblies for orthodontic prescriptions. These processes include high temperature heat treatment, tumbling media deburring, pin polishing, metal separation, and cleaning & passivation of metal components.

• Managed process validation activities (IQ/OQ/PQ) associated with both new and changed products and processes
• Developed quality procedures and specifications, and quality inspection plans for incoming material and products
• Performed risk assessment activities to update associated dFMEAs and pFMEAs
• Developed and authored test methods, work instructions, engineering studies and validation protocols
• Developed and performed DOEs and performed Minitab statistical analysis of the results for process improvements
• Evaluated process stability and capability of manufacturing processes using critical production parameters
• Assisted with the development, installation, and implementation of new tooling prototypes and process equipment
• Developed Preventive Maintenance activities and frequency for existing process equipment

Bovie Medical Corporation, Clearwater, FL 33760; July 2005 to October 2013

Manufacturing Process Engineer 

Primary responsibility was to support manufacturing assembly process for array of electrosurgical generators.

• Implemented process improvements through use of Lean-Six Sigma techniques and Quality methodology
• Authored and executed validation protocols i.e., IQ/OQ/PQ for new equipment and new process implementation and qualification
• Developed and implemented Work Instructions and Production Routers for new products
• Supported process engineering enhancements to existing products
• Maintained Quality Plans for all product lines which included process flows from incoming inspection, assembly, product testing through final packaging

Program Manager

Responsible for design transfer, regulatory compliance, risk assessment activities, and product development of product upgrade to high end electrosurgical generator.

• Managed design transfer and control activities while ensuring regulatory needs are met
• Conducted and led Design Reviews and status meetings with cross-functional Design Team
• Ensured project stayed on track and on time
• Responsible for process development and manufacturing process validation using cGMP

Service and Repair Manager

Responsible for Service and Repair Department for electrosurgical generators.

• Trained technicians on Service and Repair procedures
• Interfaced with customers directly for service and repair issues and complaints
• Maintained and developed Service and Repair workflow procedures and processes
• Implemented operation improvements to reduce cycle times, improve work efficiency and ensure timely repair of defective units

Baxter Healthcare, Largo, Florida; May 2004 to July 2005

Manufacturing Engineer

Supported development of new medical component collection systems and existing pharmaceutical medication delivery systems.  Responsible for engineering change control processes of products through utilization of GMP and GDP.  Changes may be due to the CAPA system or engineering changes through the products life cycle to improve design, production and process issues.

• Interfaced with suppliers and Purchasing Dept. to resolve procurement issues for molded parts, tooling, and key components
• Solved key component, test fixture, and tooling problems in harness area and manufacturing assembly floor
• Executed process validation protocols for new process implementation
• Resolved manufacturing issues for SMT and thru-hole PC boards of medical device products

Master of Business Administration

University of Florida, Gainesville, Florida 32611

Bachelor of Science in Chemical Engineering

University of Florida, Gainesville, Florida 32611