Melissa Patten Email and Phone Number

Building on the Operational Excellence plan that has been developed across Technical Operations (TOPS), work with key stakeholders to deploy an effective lean management system in the US region. • Co-lead lean diagnostics as required within Technical Operations. • Deploy lean thinking & systems, mainly within global operations and quality using our standardized deployment approaches. • Post deployments, provide hyper-care as required. • Build capability across the Operational Excellence community to ensure that deployment methodologies are aligned and are of the right quality. • Be available to support acute business challenges as they arise, where lean or six sigma methodologies may support effective resolution. • Work with stakeholders at all levels to deepen Operational Excellence capabilities within BioMarin.

● Facilitated discussion, decision making and conflict resolution across 2 cross-functional outbound operations product teams within the S/4HANA transformation program.● Used Agile methods and processes to coach product owners and product teams though complex problem solving and solution strategies. ● Lead manager of the Jira Guild, an expert group of Jira super admins within Boston Scientific . Established governance and change control practices within Jira. Primary creator of training Jira training content. ● Guided Agile principles and facilitation skills to ensure teams were working in an Agile mindset and utilizing Scrum practices.● Product teams representative in the Transformation Program Tools Team as Scrum Master, Jira Super Admin, Jira Align Super Admin, and Jira Guild lead.

● Expanded manufacturing engineering team from a 3 person team to a multinational workforce of 16 employees. ● Manufacturing Engineering team enabled a production volume increase of 7x over an 8 month time frame through facility expansions, line redesign and process improvements. ● Integrated 9 of Boston Scientifics’s Core systems within the first year following acquisition. ● Owner and steward of 20 business processes related to manufacturing engineering and equipment engineering (process development, process support, process troubleshooting, process validation, equipment design, equipment maintenance, equipment troubleshooting, equipment calibration, equipment validation, tooling design, tooling maintenance, tooling validation, production line design, production line maintenance, production line troubleshooting, facilities maintenance, facilities troubleshooting, manufacturing team design, manufacturing team maintenance, manufacturing team troubleshooting. ● Developed and executed a managed project for a 3x manufacturing facilities expansion, integrating and collaborating with all operations workstreams.

• Consolidated BOM and from 22 subassemblies into 3 to allow for 3x improvement in throughput and greatly enhanced continuous flow. • Implemented single piece flow manufacturing into production. • Managed engineering changes with product engineering on the introduction of new product launches using PFMEA analysis and Six Sigma principles.• Manage and monitor machinery maintenance to comply with ISO preventive maintenance guidelines.• Managed outsourced/contract vendors and suppliers including HVAC, elevators, electrical and mechanical systems.• Manage a group of engineers that design semi-custom commercial / industrial medical devices, manufacturing processes and manufacturing facilities.• Lead failure analysis reporter of a critical clinical finding using root cause analysis and material failure analysis training. • Engineering team work included cad product design, tooling, estimating, prototype and production builds.• Develop and validate new manufacturing processes and fixtures per FDA regulation (21 CFR 820 QSR).• Kicked-off facilities expansion project for a 3x manufacturing expansion into a new building (prior to BSC acquisition.) Expansion project was about 50% complete when acquisition took place.

• Oversaw execution and management of Sterilization, Finished Goods Release, Order Fulfillment, Part Conversion and Returns Processing to ensure uninterrupted supply of ovation product to US and OUS customers. • Redesigned the sterile load preparation process which resulted in a 42% reduction in sterile load preparation processing time allowing for increased scalability. • Managed finished goods manufacturing and order fulfillment staff by revising the training matrix, conducting training, and revising job descriptions to align with Santa Rosa specific roles and corporate roles. Worked with staff to develop employee goals consistent with the new job descriptions. • Supports R&D clinical and commercial initiatives by developing and releasing finished goods device history records and final labels necessary for sterilization, order fulfillment, reverse logistics and rework for Ovation Alto, Alto Autoinjector, and Ovation Balloon Expandable Stent. • Support Customer Service representatives by reviewing inventory availability and order placement. • Founding project manager for all software projects contained within the ERP Integration program (ONE QAD) that will ensure current Technology (ERP, CRM, WMS, Barcoding, Paperless transactions, etc.) are leveraged to drive efficiency throughout operations and commercial operations. • Project manager with direct communications with 46 individuals ranging from 19 different business functions, including European functions. Supports the ERP Integration projects by providing program and projects metrics and regular steering committee meetings. • Designed and operated an interconnected family of SharePoint websites supporting the 7 ONE QAD projects. • Performed cycle counting within the warehouse to ensure routine inventory counts are completed and analyzed in compliance with defined procedures.

Internal business process engineering consultant dedicated to business process reengineering efforts to enable the delivery of exceptional business process performance within US and OUS operations. Primarily responsible for facilitating process innovation, analysis, and coordination of process discovery. Myself and my team leverage information system capabilities by partnering with key stakeholders and business process owners. We work closely with all technical operations teams to analyze, present alternatives, and make recommendations on operational improvement opportunities to management. Detailed responsibilities:•Mapping of End to End Business processes to drive alignment, communications and decision making.◦Generate process flow maps from data provided through process discovery.•Help drive establishment of the Business Process Owners / Managers as part of the governance process of the Business Process Improvement effort.•Develop improvements using Lean/Six Sigma methods to ensure consistent approach to business improvement between and among teams.•Manage Business Process Improvement communications throughout the organization and presenting metric reports to management as required.•Initiates changes to operational procedures, where applicable, ensuring consistency with regulatory requirements and corporate guidelines.•Recognize barriers to business process improvement efforts and work to remove them.•Analyze complex quality and performance issues while developing appropriate recommendations.•Collaborate with the project management group to prioritize information system improvement ideas to be executed as a project.•Administer and provide process improvement training throughout all of operations including Lean, Green and Black Belt Training and Certification.•Develop intranet presence and maintain electronic database of work flows and procedures.

Process development related to design for manufacturing, lean initiatives, and six sigma. Process validation when required for the process development project. Project leader and manager for process changes. Manufacturing line support for commercial products.

Wrote and managed international regulatory submissions including original Design Dossiers for international market submissions.

Designed, developed, fabricated and tested implantable vascular prostheses and related delivery technologies. Specialized in characterization of physical and chemical attributes of medial devices using SEM and EDX.