• Lead a team of Quality Engineers and Inspection Technicians to support the production of Anesthesia, Respiratory Care, and Maternal Infant Care devices. Providing guidance, facilitating problem resolution, resource utilization, career coaching and mentoring of the team. • Ensure procedures are operationalized and deployed to employees across manufacturing, service, operations, quality, and regulatory. • Investigate and process Out of Box Failures. Working cross functionally to implement immediate solutions, determining possible systemic issues, and evaluating the need for wider controls to ensure compliance to specifications and reliable product production to improve customer expectations of quality and safety.• Manage compliance to product quality holds, concessions, and deviations. • Responsible for FDA compliance and audit readiness for Madison facility operations.• Proactively assess and implement the use of procedures, processes, tools, and policies to facilitate improvement. • Develop and drive improvements to overall Quality Management System documentation to provide clear flow down of regulations in related production and process controls areas. in simple, sustainable, and compliant processes.• Train, advise, and coach business leaders and QA practitioners on the related regulations, procedures, and work instructions. • Audit business units for compliance and consistency, and address trends observed that could lead to non-compliance or risk to patient/user safety.• Collect, summarize, and evaluate performance metrics to identify process trends that may require attention to ensure the continued efficient and compliant operation of production and process controls requirements of manufacturing.• Drive and support the development and execution of the total quality strategy for manufacturing focusing on both device regulatory compliance and product quality.

•Ensure quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibilities throughout the site.•Lead, develop, communicate, and implement strategies to ensure compliance, including site and new employee training and during crisis situations.•Investigate, develop, and implement effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions.•Provide QMS coaching and guidance to multi site teams. •Provide guidance and facilitate problem resolution throughout the product lifecycle including transfer of production from site to site.•Communicate within all levels of the organization regarding the QMS concepts of design controls, design verification and validation activities, production and process controls, Corrective & Preventive Action (CAPA), and product quality improvement. •Perform internal audits and participate in external audits interfacing with regulators.

•Spearheaded and managed the engineering aspects of a start-up technology business focused on the design, development, manufacture, and distribution of an objective measurement and tracking device for the rehabilitation and physical therapy market.•Led the strategy and implementation of the regulatory and quality requirements required to obtain FDA 510(k) certification for a class II medical device.•Created, communicated, and managed plans and deliverables for each phase of the project with limited resources to meet changing needs.•Directed, supervised, supported, and coordinated the internal project staff and engineering, manufacturing, and quality consultants.

•Reverse engineer, restore, and release existing surgical devices for the leader in the industry for reprocessing and re-manufacturing, leading to a more cost-effective greener alternative for hospitals. •Oversee, implement, and facilitate design control, regulatory compliance, and risk management activities related to new product services, sustainment of existing product services, line extensions, design changes, and process/quality improvements. •Maintain and facilitate training for all areas of the organization on department procedures and product/process services, product testing equipment, and product in-service training.

•Prepared, executed, reviewed, and approved qualification (IQ, OQ, PQ) and validation documentation in relation to instrument, equipment, and utilities. Managed validation related deviations.•Reviewed, executed, and approved factory acceptance tests and site acceptance testing (commissioning) activities. Evaluated equipment/instrument/service suppliers and approved third party generated protocols and reports.

•Developed and improved serviceability of the TomoTherapy Hi-Art treatment system, an integration of computed tomography imaging and helical intensity-modulated radiation therapy. Interfaced with all elements of the business. Facilitated the transfer of product designs into service and recommended and implemented product enhancements that would improve quality and serviceability, in accordance with applicable regulations. Created and provided guidance on risks/hazards and failure modes and effects analysis, FMEA. •Coordinated and conducted pilot site upgrades and component installations, training clinicians and field service engineers on new functionality, servicing, and troubleshooting. Ensuring service and installation documentation was created, validated, and released.•Managed and resolved customer equipment issues, minimizing down time and disruption to patient therapy. Ensured product support existed for all installed base products of TomoTherapy product lines worldwide. Continuously evaluated and monitored data to ensure product performance specifications were maintained throughout the product life cycle.

•Managed system validation and verification of a critical care ventilator for GE Healthcare as part of GE’s goal to enter respiratory market after acquisition of Datex-Ohmeda in Fall ‘03. Determined requirements-driven protocols, performing validation and verification tests using manual and automated test systems and lungs to simulate patient response to Engstrom Carestation and ongoing enhancements. Carestation features integrated ventilation with monitoring modules at the bedside.•Worked with developers and designers new to third party validation procedures, bringing a process improvement focus to department for the first time. Passed all FDA and internal audits, with auditors noting excellent continuity and traceability across all testing parameters and documentation. Identified new testing methods beyond scope of current equipment, writing proposal that won funding and testing agreement with UW Hospitals.

•Managed, coordinated, and executed system and software validation/verification and system performance testing of Aptaér Heloix Delivery System, receiving FDA 510k in record time. Product provides heloix therapy to patients with compromised airways, with sales of $18MM expected over five years. •Provided spec development, component and platform standardization, risk analysis, algorithm and anomaly analysis, validation and verification, supporting documentation, and creating and maintaining design history file. Planned and allocated machine usage, parts, timing and resources meeting all team goals despite limited resources. Reduced performance testing 75% through a more accurate and repeatable protocol. Oversaw Aptaér Product Spec and publication of the Harmonized Product Development documentation, required by FDA, CE Marking.

•Developed/validated Anesthetic Gas Scavenging Systems (AGSS) for three anesthesia machines for world’s leading supplier of anesthesia equipment. Worked cross-departmentally with supply management, manufacturing, regulatory, QA, service, marketing, and technical writers. Designed five variants to meet global acceptance, including initial design, CAD design of components, prototype development and testing, and validation/verification of subsystem to product specs and anesthesia standards. This included establishing, implementing, and documenting all design controls associated for regulatory body approval and successful product release. Worked with manufacturing vendors throughout process. •Created training material to ensure efficient and appropriate knowledge transfer of AGSS theory of operation, configuration, BOM, manufacturing, assembly, planned maintenance, troubleshooting, and installation. Conducted train the trainer sessions to facilitate and satisfy company-wide education and regulatory requirements.•Troubleshot significant water accumulation in flow sensors affecting accuracy, delivery and ventilation as identified by clinicians in the field over several years. Conceptualized and successfully tested theory of cooling CO2 absorber to aid in excessive water in breathing tube and flow sensor, leading to the re-design of flow sensor and absorber.•Took on significant responsibility with little guidance as new engineer, winning promotion to Engineer II typically earned in 3-5 years.