Minneapolis, Minnesota, United States
A passionate individual interested in successfully accomplishing organizational objectives by focusing on understanding and achieving customer needs and by developing individuals to help them realize their career dreams and goals.
Precision CNC Machine Shop serving the test systems, medical device, transportation, food, and military industries.
Provide focused oversight of the performance of our released products and leadership to continuously improve the Neuromodulation product portfolio and bring the best possible products to our physicians and patients.
Exploring a social enterprise focused on resolving customer manufacturing needs via 3D printing and prison re-entry challenges one interaction at a time.
Responsible for staff of twelve engineers and technicians and a budget of ~$5M annually. Focus of the group is to provide project leadership and design support for all of the Neurological business unit’s commercially-released neurostimulation products and therapies. Activities include projects to improve quality, usability and cost margins of released products. Serve as a key liaison between field personnel and internal resources to resolve critical patient safety, product supply, legal and regulatory issues. Have created a culture that focuses on process improvement, visual controls, standard work and accountability management. Recent accomplishments include the conceiving and implementing of a cross-functional portfolio strategy for both large-scale projects and day-to-day activities. These two portfolios total $9.5M and $40M annually, respectively. Additional responsibilities included co-developing a CAPA improvement strategy, implementing a test and communication strategy to address field EMI compatibility issues and creating an on-call technical knowledge center for the Neuromodulation Technical Services team.
Responsible for staff of six engineers and one technician that provides quality oversight for the Stimulation and Infusion Systems operations. Fostered ongoing process improvement with Operational business partners and future process development with Design business partners as well as ensure compliance to device and cGMP regulations. Responsible for oversight of Stimulation and Infusion System transfers and ongoing production at the MPROC facilities. Gained additional responsibility for the Neuro Pharmaceutical Quality group in December, 2005. Cost center responsibility exceeded $1 million.
Responsible for the ongoing quality control of all Neurological products at the Sullivan Lake facility. Responsible for insuring that all process qualifications and validations meet internal company and FDA guidelines. Supervised the Reconciler Team in charge of all internal traceability and guideline adherence. Others responsibilities included serving as the Neurological quality liaison with sister facility in Villalba, PR, implementing necessary changes to Quality Systems and managing and implementing capital projects that address major quality issues.
Served as the sole Manufacturing Engineer for the D-1300 Damper Cell (promoted to Senior QMI Engineer, effective March 1, 1998). Played a significant role in tripling the Damper Cell’s total sales over the past three years from $4 million to $13 million. Conceived, developed and implemented a plan to optimize the overall daily production from an average of 150 units to 500 units. Also, as part of a cellular management staff, assumed other responsibilities that include supervising cell operations and personnel during weekend and vacation periods, assisting planners with Kanban projects and providing information for annual budget process. Certified as a Six Sigma Black Belt. Served as the initial 2nd shift Supervisor of the Damper Cell. Activities included hiring and training entire new shift of employees, running pre-shift meetings, scheduling different product mixes and providing training in lean manufacturing concepts.