Focus areas:• Technology transfers• Regulatory Operations• Business Processes and workflows (Smartsheet/Control Center)• Design Control/Remediation

• Scale-up and continuous improvement of surgeon specialty instrument program, completing over 200 launches• Established enterprise-wide program and portfolio management process using SmartSheet Control Center, integrating 175 cross-departmental projects and top-level corporate initiatives• Implemented tiered RAID escalation process resulting in substantial increase in communication and decision-making of high priority issues at executive team level• Leadership of and growth of technical managers, engineers, designers, drafters, machinists, and technicians in a mixed remote/onsite environment• Performed program oversight and administrative activities including project spin-up, data consistency, monitoring, archiving, on-boarding, training, license allocation, and blueprint updates• Internal subject matter expert for requirements gathering, build-out and implementation of streamlined functional area and cross-functional workflows and business processes (RA, QA, OPS, E&D, F&A, HR, S&M, IT, Executive Leadership)• Business process owner for product and regulatory master data• Siemens TeamCenter PLM super-user and workflow design contributor• Determination of strategy for and execution of UDI and direct part marking updates for FDA and EU MDR compliance

Assigned with determination of new requirements (after FDA accessories ruling), process creation, and implementation of a surgeon specialty instrument program to develop FDA Class I and II instrumentation for knee, hip, shoulder, and ankle implants. After completion of the SOPs and successful implementation of the process, I transitioned into a leadership role to manage the special instrument program. In this role, I had the opportunity to build and lead a team of engineers, designers, and machinists dedicated to solving unmet clinical user needs.Other responsibilities included: • Cross-functional collaboration on regulatory and development strategies• Resource allocation of direct team, BU engineers, QA engineers, and RA specialists• Expectation management with sales force and surgeon customers• Technical documentation and specification approvals• Build-out of Smartsheet and MS SharePoint workflows and project management tools• Regular KPI updates to leadership and escalation management• Coordination of procurement, shipping, and accounting processes• Oversight of instrument refurbishment program

• Biologics development - Cartilage repair, bone graft substitutes, cell therapy products • Hip implant development - highly polished cemented stems• Surgical instrumentation development (hip, knee)• Post-market and sustaining engineering• Design control and remediation• Operative technique development

• Pre-clinical cartilage repair models (mouse, goat, pig, horse)• Chondrocyte cell culture and tissue engineering methods• Technology transfer (Taiwan subsidiary)• Alginate-based bone graft carrier formulation• PLGA scaffold fabrication

• Cardiovascular fluid management devices• Injection molding processes

• Collaborated with 3 departments on concept development of nanoscale blood oxygenator• Created finite element models to simulate oxygenator channel blood pressure loads to obtain pilot data for federal grant funding

• Designed and built equipment for characterization of thin nanoporous polycarbonate membranes to quantify effects of hydrophobic coatings

• Developed curriculum for Drug Delivery course and held office hours for student support

• Fabricated 3mm to 6mm bioresorbable PLLA stents for peripheral vascular applications