SUMMARY

• Over 15, years of experience as senior manufacturing/process engineer in developing, improving and transferring processes to contract manufacturing (CM) sites.
• Experienced within quality systems, and validation (IQ, OQ, PQ), FEMA, DMAIC, Gage R&R, NCR and statistical process control (SPC).
• Experienced in providing detailed engineering analysis and documentation, BOM, Routers and SOPS.
• Designing test fixtures and tooling for existing and new products.
• Training manufacturing staff, troubleshooting equipment and processes, and Created, developed, and maintained written instructions for manufacturing processes.
• Worked with Research and Development in the transition of products into production, Selecting and Qualifying new materials, medical material and suppliers.
• Managing and participating as a team with Quality, R&D, Sustaining Engineering, procurement, and Contract Manufacturing Organization to ensure successful transfer and ongoing production of Finished Medical Devices at Contract Manufacturers (CM’s).
• Led process evaluations/process optimization utilizing tools such as SPC, DOE, PFEMA and MSA.
• New Process Development and scale - up
• Process improvement and stabilization
• Technology transfer
• Project planning and scheduling
• Talent management, team building, mentoring, and leadership
• Lean Six Sigma green belt (Kanban, Poke Yoke, JIT, Value Stream Mapping)
• Problem Solving

PROFESSIONAL EXPERIENCE

Confidential, Mansfield, MA

Senior Manufacturing/Process Engineer

Responsibilities:

• Managing transfer and supporting of Confidential products and processes to Contract Manufacturing (CM) sites.
• Managing and participating as a team with Quality, R&D, Sustaining Engineering, Procurement, Regulatory, Sourcing and Contract Manufacturing Organization to ensure successful transfer and ongoing production of Finished Medical Devices at Contract Manufacturers (CM’s).
• Managing technical aspects of product and process transition to contract manufacturing partners.
• Ensuring manufacturing processes adequately demonstrate specified process control capabilities.
• Providing technical support and guidance to Contract Manufacturer for engineering issues.
• Conducting, coordinating and aiding in formal process validations including protocol development and execution.
• Managing all aspects of ECO process into Contract Manufacturing organization.
• Ensuring new processes have adequately demonstrated specified process and test control capabilities, through being the champion of PFMEA, DFM, DFT, DFSS, CAPA and NCR.
• Providing guidance to Contract Manufacturer in designs and evaluating new and existing fixtures and equipment, test methods, specifications, layouts and standards supporting a lean manufacturing environment.
• Ensuring adherence to product specifications, industry standards and FDA Quality Systems Regulations and ISO Quality Systems.
• Supporting process verification and validation activities.
• Selecting and Qualifying new materials and suppliers.

Confidential, Mansfield, MA

Senior Manufacturing Engineer

Responsibilities:

• Provided daily production support to set up, trouble shoot, and monitor manufacturing medical device related assembly processes and equipment.
• Identified and implemented programs that reduced operational costs, improved quality, productivity and increase yield.
• Created, developed, and maintained written instructions for manufacturing processes.
• Developed and implemented process controls for manufacturing to ensure repeatability, reliability, and quality of products and processes.
• Performed Validations (IQs/OQs/PQs) following internal protocols when new or used equipment is identified for use in production.
• Managed and participated in projects from concept to finish device, product development, medical material selection, regulatory requirements and specification, project planning, process optimization, packaging, and automation.
• Led process evaluations/process optimization utilizing tools such as SPC, DOE, PFEMA and, MSA.
• Responsible for establishing the Manufacturing Quality Plan (MQP) for a product line including process flow, production floor layout, equipment and line balancing.
• Participated in the introduction of new products into manufacturing, collaborating with R&D and suppliers to improve product robustness and manufacturability both pre-and post- release.
• Conducted root cause failure analysis and corrective action.
• Led Lean Six Sigma projects of significant scope and complexity.
• Supported business development, ISO 13485 compliance activities, risk management/FEMA activities, audits and technical training.

Confidential, Mansfield, MA

SR. Process/Manufacturing engineer

Responsibilities:

• Provided leadership to manufacturing engineering activities for process/product development, scaling of technical operations and provided technical support for production.
• Identified and implemented programs that reduced operational costs, improved quality, productivity and increased yield.
• Optimized manufacturing processes and equipment.
• Created, developed, and maintained written instructions for manufacturing processes.
• Developed and implemented process controls for manufacturing to ensure repeatability, reliability, and quality of products and processes.
• Provided training to production personnel on processes and equipment.
• Worked with Research and Development in the transition of products into production.
• Actively participated in the development of new products and processes to promote business growth and productivity targets, including scale-up, equipment and process qualification and validation.
• Reviewed product field returns to determine root cause of potential manufacturing defects then developed and implemented effective corrective actions
• Utilizing Lean/Six Sigma manufacturing methods to improve processes and reduced waste.
• Drove root cause identification and resolution of process and product upsets.
• Monitored and improved processes using statistics and SPC.

Confidential, Marlboro, MA

SR. Process Engineer

Responsibilities:

• Provided technical leadership implementing major capital projects.
• Provided hands-on problem solving support to manufacturing/testing of specialty chemicals.
• Identified and led activities for improvements related to safety, cost, quality, yields, capacity, and production goals.
• Optimized processes using Lean manufacturing and six sigma methodology, developed and implemented improvements to processes and production operations, resulting in 36% improvement in productivity.
• Analyzed operating data from manufacturing processes using statistical tools, both proactively (statistical quality/process control) and reactively (troubleshooting).
• Assisted both production and maintenance personnel in troubleshooting and correcting problems related to yields, quality and environmental compliance.
• As necessary, assisted area leadership and developed leadership skills through interaction within manufacturing team.

Confidential, Worcester, MA

Senior Process Engineer

Responsibilities:

• Supported all manufacturing areas used in the fabrication of IC’s and sensor products during 12 hour shift.
• Developed and improved manufacturing methods and procedures and equipment directed at reducing costs while maintaining quality standards.
• Developed quality specifications and requirements for all products.
• Supervised staff of 8 process engineering personnel.
• Appropriately dispositioned discrepant material using NCR system.