Supporting the innovation and manufacturing of ENT, Ophthalmology, Sterile Processing devices and many others!

Advanced Device Manufacturing, and Hydrophilic coating device Manager.Leading a team of 7 supervisors, about 200 associates across 4 shifts and two buildings.

Eliminated 20% OT and increased efficiency (2.09 to 1.14 hours per part).Created layout, project funnel, metrics to hit goals.Managed 2 production supervisors with over 60 operators in two different shifts.Implemented GMP into the production line.Created favorable variances in labor that amounted to over $1M in one quarter.

Transitioned into engineering when Spectranetics bought a product that was divested by Covidien.

Responsible for integrating corporate initiatives to drive alignment with company policies on quality and safety culture.Manage focus factory metrics such as labor efficiency, service level, yields, and financial goals for a Drug Coated Balloon (DCB) device.Manage the manufacturing team to launch a new product line after going through the validation process and submissions to the FDA.Lead a team of direct reports that include Supervisor, material handler, production lead, and the manufacturing associates.Co-lead an employee engagement group to drive positive culture in the work environment.Work with R&D and multiple other cross functional teams to solve issues that arise to improve current processes and deliver reliable product for our customers.Create, develop, and implement metrics (yield files, scrap codes tracking, paretos, etc.) to track financial goals (MUV and PPV) and achieve future steady state budgets. Work with cross-functional teams to come up with a COGS model, and create/implement BOM's.Create and integrate new lot segregation, 5S, safety, and quality practices to improve manufacturing process.Manage updates of documentation with engineering team to help achieve targets and milestones.Own and support CAPA's and NCR'sWork with engineering to support production and CIPsCreate/develop facility layoutsHelp coordinate timing and resources with Change Orders and validation activitiesEnsure compliance with all company and Federal requirements for the production area and personnel

Responsible for focus factory metrics such as labor efficiency, service level, yields, and financial goals.Lead a cross-functional team to drive for root cause analysis and put effective countermeasures to develop cost effective tangible solutions that impact the business.Delegate responsibilities effectively with high comfort level to a diverse environment.Support/Implement better management reporting, information flow and management, business process and organizational planning.Ensure product and process quality is held to a high standard to exceed industry and customer requirements.Work with four transfer teams to transfer a $6 million COP budget.Work with the operations plant manager to present monthly and quarterly operations metrics to upper management.Lead time studies and line balancing strategies to increase output by 78% in a span of one month.Maintained schedule and create files for attainment rates at 100% for the plant that helped fulfill inventory requirements for plant shutdown.Achieved positive labor variance and favorable overhead absorption through driving operational improvement programs across the production floor.Managed a manufacturing analyst and twenty-one hourly employees.Applied lean tools to eliminate bottlenecks to result in a high volume, and decreased lead time process.Lead employee engagement activities to boost morale during a plant closure.Work with multiple cross-functional teams to transfer 4 production lines from the San Jose site.Responsible for production ramp-up to achieve challenging inventory goals using lean six-sigma tools and previous supervisor experiences.Support the successful transfer of medical devices with a challanging timeline, and work with a cross-functional team to improve the product and make it more robust.Converted Manufacturing Procedures from old format to new format.