Responsible for providing tactical leadership to implement and manage the organization’s enterprise risk management (ERM) program to enable informed decision-making by senior leadership. Works closely with all corporate functions and business units to assist in risk identification, quantification, and management models. The ERM program encompasses risks across the entire organization, including but not limited to risks related to health, safety, environment, and security (HSES), information and technology systems (IT), supply chain and procurement, business strategy, finance and controls environment, legal and human resources. -Support the design, implementation, and management of the ERM framework:---Strategy and objective setting---Risk identification/revalidation---Risk assessment---Risk management /response and control plans---Communication and monitoring---Audit, assess, adjust.-Develop ERM policies, procedures, and guidelines.-Document ERM processes and controls using tools, flowcharts, or narratives.-Develop risk registers and facilitate risk workshops to capture emerging risks.-Provides ongoing monitoring and support for the management of risks and develop early warning indicators for proactive monitoring.-Identifies trends and interdependencies throughout the support functions and business units and facilitates conversations with various functions throughout the company to ensure alignment and consistency in the management of risks.-Serves in a consultative capacity (subject matter expert) to support functions and business units on risk related matters.-Assist Insurance Risk Manager in insurance policy renewal process.-Works with internal audit to support risk-based audit program and planning or special projects.-Participate in business and enterprise level strategic projects and lead key elements of risk management development and improvement initiatives.

The Global Process Safety Program Manager is accountable for assuring process hazard assessment competency and that high severity/high probability process risks are being mitigated through necessary prioritization, training, and resourcing.-Providing expertise input on process, engineering and risk assessment methodology (e.g. Qualitative or Quantitative tools) to support development of overall global process safety programs.-Provide training and hands-on coaching through leading and/or facilitating process risk assessment to build up and enhance process safety competency.-Conduct and/or participate in compliance audit on process safety management.-Identify the common process safety challenges across global sites and assist with development of improvement focus and plan.-Assist in developing and implementing company corporate safety programs and initiatives.-Review process safety incidents to ensure they are properly classified and investigated. Share learnings across the global organization.-Assist facilities in follow-up on action items from process safety audits.-Ensure that global organization has the appropriate tools to manage process safety elements (e.g., PHA software, MOC, incident investigation).-Provide process safety support and recommend solutions to engineering, project, and daily operations to execute process safety requirements and to ensure compliance with corporate process safety standards and/or local requirements.

Responsible for all aspects of compliance to federal and state regulations regarding process safety management of the manufacturing facility. This includes but is not limited to: participation in OSHA and EPA audits, facilitation of the management of change (MOC) process, and collection, maintenance, and organization of all information related to the 14 elements of OSHA s PSM Program.-Provide overall leadership and compliance with federal regulations and other safety policies for PSM elements ensuring audit readiness.-Participate in OSHA and EPA audits.-Determine the necessary risk mitigation for an accident scenario during PHAs/HAZOP, or as a stand-alone task.-Provide support/coordinate LOPA reviews for risk scenarios requiring further assessment post PHA review (SIS Design & Human Factors Studies).-Collaborate with Superintendents/Project Engineers to develop capital requests for process hazard analysis recommendations (PHAR) and lead projects to closure.-Train and strengthen site PSM custodians in their PSM related duties and specific procedures/directives-Provide overall leadership for Facility Siting.-PSM Auditing (Local and Off-Site).-Evaluate new technologies and new/modified products/processes as they relates to PSM.-Coordinate, facilitate and document the PHA/hazard evaluations of new and existing processes.-Provide leadership for management of significant, though unregulated, process safety risks -Track and follow-up on action items with timely completion; addressing findings from PSM audits, hazard analyses studies, and other generated PSM or RMP assessment activities.-Manage PHA revalidation schedule.-Lead Management of Change (MOC) process-Participate in Process Safety event investigations/root cause analysis-Lead, development of internal policies, practices, procedures, design guides and engineering standards.-Develop/update unit reactivity matrices to determine hazardous effects of mixing of varied materials.

-Partner with the Product Operations Leader, the Value Stream Leaders, Regional Technical Leader and Manufacturing leadership to understand and support the business objectives and meet technical needs-Mentor, sponsor, and lead technical associates supporting the value stream, including setting expectations and evaluating performance against those expectations-Provide product line leader and/or manufacturing review and approval, as appropriate.-Assist in prioritizing and implementing manufacturing improvements-Understand and provide input to the future state of the value stream and assist in strategically defining the future state of manufacturing for the processes of the value stream -Build consensus, and drive the changes necessary to achieve the future state-Facilitate alignment of projects for technical associates in concert with business goals and associate development needs-Provide subject matter expertise in support of both internal and external audits-Resolve cross-discipline and intra-team issues-Help develop team priorities for use in the P&D process and help associates Activate new Goals and assist associates in the Align reviews.-Assist and provide leadership and guidance to associates as they: -Develop, execute, and analyze experiments based on statistical techniques -Perform and write validations of processes and equipment in accordance with appropriate guidelines -Write procedures and train associates to those procedures -Update product documentation to meet current MPD and Regulatory Agency requirements -Execute on line extensions and submissions

Process/Product Quality Engineer supporting Patch PLUS Antimicrobial Medical Devices• Primary engineering resource and subject matter expert for antimicrobial coating process for implantable medical devices.• Won technical awards for overall technical excellence, risk management steward, statistical ability and regulatory validation efforts• Primary engineering resource for operation and maintenance of RO/DI water system for process/product contact with implantable medical devices • Responsible for all product quality related investigations (NCR, CAPA, FIR)• Execution of engineering analysis for combination product material degradation• Planning, executing, and analyzing experimental design to validate equipment, process and test methods• Experience with cGMP and gap analysis to transition Class III implantable medical device to combination product• Subject matter expert for process transition to automated manufacturing system through effective cross functional collaboration• Monitoring product performance metrics

Product Quality Engineer supporting BioAbsorbable Polymer Implantable Medical Devices• Defining, developing, supporting, and improving performance tests and visual inspections to evaluate and verify key properties of raw and intermediate materials, designs, processes, tests, and finished devices• Developing and applying a fundamental understanding of product properties and performance in conjunction with product managers and engineering teams• Provide day to day support for existing device manufacturing and the development and transition of new products into manufacturing• Troubleshooting and refining device design• Planning and executing equipment, process, test method, and product validations• Design, execute, and analyze experiments using statistical techniques.• Monitoring product performance metrics• Creating procedures and training other technical and manufacturing associates• Operating within the Gore Medical Division quality system (which ensures compliance to FDA and ISO guidelines) including the following: product surveillance, corrective and preventive action, risk management, and design control

• Staff promoted R&D engineer for the oxidation and finishing process at a TiO2 facility. • Lean six sigma green belt certified with documented savings of $100k+ reoccurring annual basis. • Formal black-belt training with current project savings in excess of $500k per year. Strong statistical analysis skills and business acumen to drive bottom line results. • Personally took on extra work to improve product quality measurement technology. Qualified new equipment through Gage R&R studies. Lead quality improvement projects that resulted in significant reduction in customer quality issues.• Site product steward who worked closely with quality manager in an ISO 9001 continuous production facility. Direct experience in ISO recertification process. • Technical support for projects ranging from gas analyzer installations to new grade development. • Leadership roles in continuous improvement projects and global process hazard analyses. • Working knowledge of SAP systems for new equipment installations, routine maintenance, and emergency maintenance requests. • Performed routine technical documentation (process change, standard job procedures, basic data packages, process hazard analyses, etc).• Strong Microsoft Office skills. Developed macro-based Excel workbooks to monitor process variables, product yield, and quality. Improved interface lead to improved reliability, increased yield, and reduced quality incidents.

• 20-25 hr/wk extra-curricular work assignment.• Initial work tasks ranged from fuel cell fabrication, standardization of procedures & recipes, to developing a cell efficiency tracking system from cradle to grave.• Later work assignments in CO2/SO2 capture focused on potential synergies between different amine compounds for elevated adsorption with minimal residue. Standardized testing procedure to improve comparability between samples

• 8 month co-op assignment in lab based environment. Focused on Gage R&R of new equipment, standardization of test procedures, and qualification of new product formulations.• 4 month co-op assignment in production facility. Focused on standardization of batch polymerization procedures to improve product quality and improve yield.

• 3 month co-op assignment in lab based environment. Focused on qualification of new product formulations. Familiar with ISO-9001 lab quality procedures, equipment calibration, and certification process.