Helping individuals, teams and organizations transform by applying Lean, Six Sigma and Organizational Change Management (OCM).

Established and expanded the training department at the new MitraClip manufacturing site. Influenced the initial implementation of Lean and helped adapt the approach as the site grew.

Led four OCM workstreams to support startup of the new MitraClip manufacturing site in Westfield, Indiana.

Helping transform individuals, teams and organizations:-Strategy Development-Change Management-Project Planning & Implementation-Team Effectiveness

Led and coached completion of high priority business transformation projects prioritized by the CEO, Executive Committee and VP's. Applied tools such as strategy development, Lean Six Sigma, Organizational Change Management, Organizational Architecture, Blueprinting, Belbin Team Roles, and IBM BlueWorks Live.

Coached 15 black belts. Led a project to streamline the adverse event and product complaint handling processes that resulted in significant productivity improvement. Taught courses on Lean Six Sigma, Organizational Change Management and Organizational Architecture. Led workshops on Belbin Team roles and meeting effectiveness. Facilitated workshops and used IBM BlueWorks Live to redesign clinical development processes.

Led completion of medical device related regulatory submissions (e.g. FDA Biologics License Application (BLA) section 3.2.R.5) for new combination products (autoinjector and pre-filled syringe) which led to numerous global approvals. Led completion of mobile medical app regulatory submission (FDA 510(k)) which led to US clearance. Became subject matter expert on regulatory expectations regarding Human Factors. Facilitated the internal cross-functional Device Hub to share best practices and… Show more Led completion of medical device related regulatory submissions (e.g. FDA Biologics License Application (BLA) section 3.2.R.5) for new combination products (autoinjector and pre-filled syringe) which led to numerous global approvals. Led completion of mobile medical app regulatory submission (FDA 510(k)) which led to US clearance. Became subject matter expert on regulatory expectations regarding Human Factors. Facilitated the internal cross-functional Device Hub to share best practices and external trends. Show less

Led 5 Lean Six Sigma projects with a total savings of about $1mm. Coached green belts.

Led a project that resulted in decreased cycle time and increased response rates for obtaining adverse event information from external health care professionals.

Served as project manager to initiate and manage two new external suppliers of adverse event services. Facilitated the internal Operations Forum.

Provided leadership for a staff of 30+ for support of medical device product development and manufacturing. Ensured effective and compliant site Quality System aligned with ISO13485 and the US FDA Quality System Regulation (21CFR820). Aligned the Quality System with ISO13485:2003 and earned ISO certification for the site. Facilitated the Device Safety Lead Team, and chaired the site Quality Lead Team. Served as Six Sigma project champion and process owner.

Responsible for medical device (reusable pen injector) lot release, complaint handling and development project support.

Collaborated on the development of a new pre-filled insulin injector and an insulin inhaler.

Co-led the development and launch of new durable medical equipment for the bariatric market. Conducted research and prepared recommendations to enter the hospital supply management and infection control markets.

Led 5 sub-teams through the development of a Manufacturing Strategy for the Frames and Equipment division.

Conducted external supplier quality audits. Participated in Lean Process Kaizen breakthrough events. Led the External Supplier Quality Team for JIT implementation.

Provided support for two heart catheter manufacturing lines with responsibility for final lot release. Supervised 4 final inspectors. Coordinated validation of medical device manufacturing lines after moving them to facilities in US and Europe.

Led over 50 external medical device component supplier audits to ensure compliance with US GMP and ISO requirements. Developed and approved new suppliers in partnership with R&D. Managed the supplier corrective action process.

Coordinated development of Affirmative Action Plans for 3 sites. Facilitated the development of the Manufacturing HR Strategy. Co-led the Job Posting system benchmarking project.

Led the development of manufacturing strategies, coordinated supply chain analyses, and improved product development processes at Lilly-owned subsidiaries (IVAC Corporation (San Diego); Hybritech, Inc. (San Diego); Cardiac Pacemakers, Inc (St. Paul); Physio Control (Redmond)). Served as team leader and facilitator for continuous improvement projects.

Performed on-site inspections to identify and minimize risks from fire, explosion, and natural disasters.