Sean Kehmeier Email & Phone Number

Boulder, Colorado

Hired to sustain manufacturing production and increase quality, throughput, and efficiencies through Lean and Six Sigma practices.

Boulder, CO

• Promoted to Advanced Manufacturing Engineering (AME) product core team lead to establish efficient and cost-effective manufacture of energy-based surgical generators.
• Accomplished year-in-year-out on-time product launch while meeting targeted product COGS, quality, and safety metrics driven by risk-based and Six Sigma (DMAIC/DFSS) product development practices.
• Slashed manufacturing assembly time and labor requirements by 50% for new product over predicate medical devices through employment of DFM, DFA and DFT improvements to product and manufacturing processes while meeting.
• Expanded SPC monitoring and product quality data analysis of manufacturing processes through development and validation of data communication and storage of CRio and PLC data generation.
• Drove consistency in contract manufacturer (CM) production through standardization of CM specifications and defined standards for device master record (DMR) control within the product life cycle management (PLM).
• Achieved and preserved Authorization to Mark for generator products through the management of product compliance with IEC 60601-1 3rd Edition by management of affected critical components, product electrical safety.

Boulder, CO

• Hired to integrate acquired suite of RF Ablation product BOMs and component stock with resident PLM and MRP system, implement component obsolescence tracking and resolution program, and to revise, maintain, and verify.
• Evaded production line down, reduced supply chain risk and obsolete component usage in new designs through tracking of tens of thousands of parts by part EOL and part changes and increased annual cost savings through.
• Enabled continued production of flagship electrosurgical generator by redesigning its controller PCBA for a replacement FPGA prior to original part stock-out.
• Reduced manufacturing defects by promotion and implementation of upstream PCBA testing through redesign of PCBAs for ICT at board house manufacturer.
• Attained continued product penetration in worldwide markets through creation, management and implementation of RoHS compliance transition project for tens of thousands of components spanning company energy-based.
• Created approval process and documentation requirements for control, verification, and validation of component approved source of supply within the Agile PLM System to maintain component quality control.

Bachelor Of Science (Bs), Civil Engineering

Bachelor Of Science (Bs), Electrical And Electronics Engineering