Responsible for leading Pre Market Quality, External Supplier Quality, Risk Management and Quality Engineering functions for Neuromodulation and Pelvic Health Operating Units.Lead staff of 8 direct reports with total organization of 43 engineering and technical professionals.

Responsible for leading Post Market Quality, Internal Supplier Quality and Post Market Surveillance functions for Neuromodulation and Pelvic Health Operating Units.Lead staff of 6 people managers and an organization of 30+ managers, program managers and engineers.Responsible for representing product quality in external inspections/audits.Participate as core member of General Manager's leadership teams.Chair Issue Escalation process and make recommendations/decisions related to actions for product issues in the field.Represent Quality function in cross functional governance of post market work prioritization.

• Responsible for organizational execution of all requirements within Neuromodulation Consent Decree• Lead contact with 3rd party expert for the consent decree for audits and issue resolution• Represented Neuromodulation in FDA inspection as lead (Front Room lead, CAPA area lead, and 806 reportability expert), in final FDA inspection required per the consent decree. Inspection resulted in zero observations.• With a staff of 21, department is responsible for CAPA domain, quality data analytics, process validation and regulatory compliance within Neuromodulation, including interfaces with all partnering areas (Risk Management, Field Actions, Design, Regulatory, etc.) o Implemented a revised process resulting in reducing CAPA aging by 50% within 6 monthso Creation of process monitors for quality system work to ensure state of control is maintained

• Responsible for field action process, execution, and regulatory reportability decisionso Negotiated with external regulators on key aspects of field action plans (press releases, scoping, reportability, classification, etc.)o Documented decisions for scoping and reportability decisions that were subsequently reviewed by FDA in inspections with no concerns• Led service department with staff of 18 and returned product lab with staff of 20o Led department to identify and complete cost savings initiative within 6 months that resulted in 3MM+ annual cost savingso Department identified multiple quality issues that resulted in recalls initiating months prior to any signal being detected by complaint trend analysiso Led department during COVID controls creation and implementation as department was required to continue work on site

• Lead team of 9 individuals supporting entire division in CAPA execution• CAPA Board Chair for division and responsible CAPA oversight decisions• Defended CAPA process area (QSIT and MDSAP styles) to external and internal auditors, including linkages to other QMS process areas

• Led creation of two brand new CAPA boards • Developed training for new CAPA owners on CAPA problem solving process and methodology• Coached CAPA owners across all areas of the business

Responsible for managing multiple, concurrent technology development projects. Projects included research of new features, integration of new components, development of system firmware and software, wireless (900MHz and 2.4 GHz) firmware development, and regulatory support of a 510(k) commercial product. Work with teams composed of cross-functional membership including technical and non-technical specialties. Utilized waterfall and Agile project management methodologies. Primary responsibility to lead planning, execution and risk management during a project. Regular interaction with senior and executive management on project status, needs, issues and business prioritization.

Provided quality engineering support for both pre and post commercial projects representing multiple suppliers. Product types have ranged from commercial electronics to drug infusion kits and surgical equipment. Responsibilities include daily support of the manufacturing processes at the suppliers, conducting quality system audits, participating in product redesign efforts, leading manufacturing transfers, leading cross functional CAPA teams to analyze product issues, determine root cause and implement corrective actions. Work has included international suppliers in Puerto Rico and the Far East. Significant accomplishments include:• Pulled in a transfer project schedule by 15% to avoid a product stock out • Reducing process lead times resulting in 200 person hours of time savings per year• Leading cost reduction initiatives• Leading a cross functional project team to meet and exceed a deadline set forth by the FDA for specific product updates• Revising divisional metrics and objectives around the product deviation process• International travel including Puerto Rico, China and Malaysia

Supported both the Prostiva and InterStim therapies. Work included reviewing design and manufacturing engineering changes for regulatory impact, participating in cross functional creation and review marketing promotional materials, leading a cross functional team to provide inputs to FDA guidance documents, and participating in a core team as the regulatory lead.

Assisted professional equipment engineering project managers in building equipment for a commercial product line. Duties included tracking project deliverables, updating the project schedule, managing capital finances and completing departmental work requests. Other contributions were assisting in revising departmental procedures, tracking project change requests, and resource management.

Was assigned a project to evaluate, recommend and implement a technology solution to measure potential contaminants of medical devices. Main focus was comparing multiple technology options and determining the ideal path for a solution. Other duties involved vendor interactions, presentations to management on recommendations and training of professional staff.