Mike Hoff Email and Phone Number

Site leader for manufacturing operations.

Oversee all technical activities in support of the start-up of a new 105,000-sqft biotech manufacturing facility. This includes project management, construction general contractor engagement, equipment selection and procurement, commissioning, qualification, validation and technology transfers associated with the move from the existing facility to the new facility. Support engineering team's development of new processes and refinement of existing processes. Work with cross-functional teams to transition the current tissue product to a biologic classification by documenting a future Biological Licensing Application with the Food and Drug Administration.

Project management responsibilities to support the start-up of a 180,000-sqft medical device manufacturing facility. This included the placement and qualification of over 160 pieces of equipment, hiring and building technical resource teams and alignment and creation of Good Manufacturing Practices to comply with FDA regulations. This included the insourcing and launch of several product families previously only manufactured at vendors.

Manage process transfers between Zimmer Biomet sites considering the financial impact associated with each move.

Warsaw Site Lead for Production and Process Control (Process Validation) remediation to review and re-execute 269 process validations within a 21-month period including $30M expense and $30M capital budget. This included weekly report-outs to executive management, monthly report-outs to the Executive Leadership and quarterly communication to the FDA to confirm progress metrics were met. Zero FDA audit findings associated with process validations during the two years that this was executed. Accountable for the leadership of eight engineering managers and over 175 engineers and technical resources.

Manage technical resources to support eight hip stem manufacturing cells on three shifts. Team successes include an average lead time reduction of 50% across all process flows, on-time deliveries improved from 18% to 98% and scrap reduced by 19%.

Manage projects between global locations. Completed the transfer of an articular surface product line from Warsaw, IN to Puerto Rico. Also led an outsource project of an aseptic fill process from Zimmer to a contract manufacturer in the Netherlands.

Manage engineers responsible for new product launches. Also led an outsource and an insource project.

Managed 10 production cells. Responsible for up to 20 direct reports including engineers, supervisors, and clerical personnel. Also responsible for up to 300 production operators across three shifts. Managed a $30 million annual budget.

Launched new product projects in Knee Manufacturing. Projects included implants and provisionals for knee femorals, tibia base plates, and articular surfaces. Responsible for up to eight engineers and three CNC programmers.

Supported engineering assignments on the production floor and led new product launches at automotive customers such as Ford, Chrysler, and General Motors. Represented the company in QS9000 audits and customer visits.