• Technical lead on all new product introduction (NPI) activities. Successfully introduced instrumentation system for sub-scapula rib fixation with including sterility tray validation execution and reporting, managing all first article acceptance activities, and development of gaging, fixturing and inspection techniques with supporting instructions and documentation.• Built and maintained all aspects of the business relationship with OEM supplier to utilize a dental drill in thoracic surgery, including development of custom contract defining quality, regulatory, supply chain and business terms.• Overhauled and optimized sterilization process for bio-resorbable implant to improve yield from 70% to 100%.• Managed all aspects of supplier management: supplier evaluations and audits to ISO and FDA requirements, corrective actions (SCAR’s), regular performance analysis and reporting.

• Led cross-functional cell team to develop and improve manufacturing process instructions for swiss lathe machining, deburring, tumbling and polishing processes.• Primary team member in cell wide continuous improvement system; most notably implementing tool life limits on the top five producing part families to improve post-machining cycle times, thru-put, and overall cell efficiency.• Professional and effective communicator to all levels within an organization, with experience presenting improvement projects with ROI justification, scorecards/KPI’s, pareto charts and improvement plans to upper management.• Investigated internal and external product non-conformances (QN’s) including disposition, failure mode trending analysis, and any necessary correction activities.

• Lead R&D engineer on multi-million dollar, technical, high priority medical device product and process development projects. Spearheads efforts to launch products with practical design, tooling and technical documentation into a large-scale manufacturing environment.• Assembly engineering lead for new product introduction (NPI). Reviews customer prints for clarity, GD&T, and DFM. Leads technical discussions with customer engineering teams to resolve design and manufacturing concerns, and assesses production readiness of processes in order to successfully implement new products. • Hands-on engineering approach. Thrives in technical environments where direct engineering involvement is used to better design products or processes. Excellent technical communication skills and builds good rapport with technicians and operators to gain knowledge of critical processing details.• Key member of product development cross-functional team(s). In accordance with ISO 13485, developed process maps, documentation plans, and risk analysis (FMEA’s) to guide products through validation (IQ, OQ, PQ) and into production with safety and efficacy paramount.

• Successful at process development with extensive first-hand experience with DOE’s, fixture and machine design, FMEA’s, qualification, documentation, and process optimization in a fast-paced, high energy work environment.• Essential team player in new development projects with expertise in evaluating technical drawings and specifications for proper GD&T and DFM, forecasting new product development efforts and equipment into scalable manufacturing.• Developed innovative fixturing for new or current product development. Increased run rates and productivity on various assembly lines by as much as 100%• Engineered and troubleshot solutions for automated equipment (PID’s, temp/motion controllers, pneumatic actuators, etc.) to increase process yield, control, and sustaining efforts.• Excellent communication skills, charisma, and tact. Numerous successful encounters with customer engineering and sales teams to build working relationships and promote future business.

-Skilled in management operations including tracking productivity, coordinating manpower and resources, project scheduling and meeting strict deadlines.-Worked within budget and time constraints on all phases of projects, including budget structure, job cost management, change order pricing, start-up and close-out procedures, commissioning, and warranty items.-Organized and facilitated document control systems within MS Excel, MS Word, and Viewpoint (construction management software). Responsible for upkeep of all contract documents including as-builts, RFI’s, submittals, pricing, etc.-Experienced in reviewing construction blue prints and project documents for accuracy, practicality, and affected cost.

•Most reliable sales associate specializing in sales of soft goods and technical outerwear. Never was late for a shift and willing to work double shifts at a moments notice.

-Designed production components for automotive tooling assemblies. Specialized in gear train design and peripheral hand tool components.-Skilled in tooling and fixture design to support manufacturing. Created a variety of innovative fixtures to establish standardization in production, run rate optimization, and increased tool reliability. -Developed assembly process manuals, drawings, and document control systems -Hands on experience with tool assembly and fabrication, including CNC mills, surface grinding, manual lathes, hydraulic presses, and welding.

-Streamlined various manufacturing processes and routings to optimize production costs and efficiency via SAP management software. -Diagnosed and corrected QC issues utilizing CMM, mechanical gauge testing, and root cause analysis techniques. -Revised drawings for ISO 9000 compliance, regulatory compliance issues (RoHS), BOM's, and overall accuracy.