Susan Butkus Email & Phone Number

Marlborough, MA, US

Marlborough, MA, US

Marlborough, MA, US

• Provided reliability support to ensure successful launch of EKOS CU4 control system.
• Provided Product Software Design Assurance support as well as Manufacturing Quality support for system relaunch.
• Provided onsite support for EKOS integration as part of the BTG acquisition.

Marlborough, MA, US

• Manage system, hardware, and software design assurance engineers.
• Deployed divisional systems approach to development and test activities.
• Represent division for global harmonization activities, specifically: design control, medical electrical equipment, software development and validation, cybersecurity, and risk management.
• Develop reliability program for system and hardware evaluatons.

New Brunswick, NJ, US

• Managed site quality department, including inspectors and engineers, establishing priorities and resource allocation to support base business, new product development, and externally produced components and products.
• Successfully hosted Animas Vibe Pre-Approval Inspection (PAI). Served as site management representative. Hosted notified-body audits, including FDA, BSI, and J&J corporate site inspections.
• Improved site quality metrics from mostly red to all green; facilitated continuous improvement activities.
• Served as Quality Lead for Issues Escalation as well as Corrective and Preventive Actions (CAPAs).
• Partnered with other critical business functions through daily interactions, meeting, and cross functional teams to deliver compliant, continuous flow of quality products.
• Provided leadership for J&J Process Excellence initiatives including six-sigma, design excellence, and lean principles.

New Brunswick, NJ, US

• Managed quality engineering team, including project scheduling, skill developing, and coaching, for base business, new product development, and supplier quality activities of capital electro-mechanical and single-use.
• Utilized techniques such as risk analysis, test method development, design of experiments, statistical data analysis, measurement system analysis, and development of sampling plans throughout the product lifecycle to.
• Partnered with Operations, R&D, QRC and other departments to ensure products are efficiently and effectively transferred and integrated into steady-state manufacturing.

New Brunswick, NJ, US

• Served as interim manager of business unit Quality Engineering (QE) resources.
• Functioned as project quality engineering lead, coordinating support of design, software, supplier, and manufacturing quality engineering tasks on PMA and 510(k) products.
• Served as Subject-Matter Expert and provided back-room support for notified-body audits.
• Led electromechanical (EM) new product development capability assessment team and EM design control implementation team.
• Developed corporate procedures for electromechanical system reliability and statistical methodologies used during product and process development, design verification and validation, and process validation.
• Mentored others on risk analysis, test method development and validation, statistical data analysis, statistical process control, reliability engineering, computer system validation, and development of sample plans.

New Brunswick, NJ, US

• Provided reliability and quality engineering support on new product development (NPD) and lifecycle management (LCM) project teams for Class III (PMA) and 510(k) products.
• Served as company subject-matter expert for statistics, product reliability, and medical device risk management.
• Developed methodologies for evaluating and improving product reliability on new and existing products.
• Mentored others on statistical methodologies to support problem solving as well as verification and validation activities.

New Brunswick, NJ, US

• Supported new product development teams for Gynecare electro-mechnaical systems as Quality Engineering team member.
• Developed corporate methodologies for electromechanical system reliability as well as appropriate statistical sampling and analyses.
• Implemented product software quality engineering process.
• Utilized Six Sigma methodologies to solve problems and develop optimal products and processes.
• Partnered with R&D to ensure the correct application of design control and risk management.

Lynnwood, Washington, US

• Managed reliability engineering team, including project scheduling, skill developing, and coaching.
• Monitored company field performance metrics and facilitated continuous improvement activities.
• Added value to product design by expanding reliability activities and involving reliability further upstream in the product development process.
• Provided safety and reliability input into proposals and reviewed contracts for impact.
• Mentored black belt candidates.
• Provided statistical analyses for six-sigma projects, proposals, and troubleshooting activities.

Azusa, California, US

• Reduced Finished Goods quality rejects by 50-percent.
• Led platform quality improvement team.
• Supervised (15-20) inspectors over three shifts.
• Implemented Short-Run Statistical Process Control (SPC).
• Developed and implemented ISO 9000-based plant quality system.
• Provided training in structured problem solving.

New Brunswick, NJ, US

• Reduced qualification testing manpower and time by 90-percent.
• Provided statistical design and analysis support for research and development, manufacturing operations, clinical studies, and marketing on two new product programs.
• Mentored black belt and green belt candidates.
• Optimized reference systems methods.
• Implemented company-wide Test Method Validation (TMV) methodology.

Carlsbad, California, US

• Minimized golf ball development time by designing and analyzing statistically based factorial and mixture experiments.
• Constructed models and response surfaces to visually assist in product/process optimization.
• Led teams in decision analysis studies.
• Established process control methodology for high-volume automated manufacturing facility.
• Participated in the evaluation and provided approval of manufacturing equipment and material suppliers.
• Developed and conducted company-wide training in SPC.

Urbana-Champaign, Chicago, And Springfield, IL, US

• Wrote and web-enabled simulation and analysis software for SPC and Design of Experiments (DOE) computer workshops.
• Conducted data mining analysis of Illinois Department of Child and Family Services database to develop models to improve child placement.
• Taught Analysis of Data course and selected material in SPC and DOE classes.

Detroit, Michigan, US

• Coordinated establishment and deployment of supplier modeling requirements with a cross-divisional team, including key suppliers.
• Implemented Integrated Vehicle Electrical Design (IVED) process into electrical engineering analysis.
• Identified discrepancies between software capabilities and desired process and developed corrections.
• Modeled electrical components/systems and conducted computer-simulated analyses for vehicle power and signal distribution systems.
• Communicated final analysis results, including any recommendations to systems and components engineers.

Detroit, Michigan, US

• Reduced warranty over 75-percent, resulting in over $1 million annual savings.
• Increased customer satisfaction ratings over 50-percent.
• Led engineering/manufacturing/marketing product improvement teams.
• Accelerated problem solving through improved team communications.
• Achieved lowest number of unresolved issues at pilot for any new truck platform.
• Revised new model product assessment and improvement activities.

Ms, Statistics

Bs, Electrical Engineering