Experienced Medical Device Professional with a focus on Project Management and Development.

Project Lead for multiple, complex projects strategic for the Smith & Nephew ENT franchise.

-Development Engineer leading Knee Remediation Teams to bring Legacy Design History File documentation to current standards; critical member of Design History File Remediation Effort, focused on Design Control document remediation. Coordinated cross-functional resources and deliverables. Supervised workload of 5+ contract development engineers. Communicated management decisions downstream.-Leading and co-engineering early stage New Product Development Knee Projects during merger and in new Zimmer-Biomet era.

•Designed and led project team for lumbar interbody line extension. Project consisted of in-between implant sizes in addition to instrument tray reconfiguration, additional trials, and establishment of shorter sterilization cycle time.•Designed and led project team for transition pedicle screw re-design of fusion to dynamic segments, focusing on international market requirements and compatibility with existing implants and instruments. •Led engineering investigation of device failure modes, including completion of verification protocols and reports along with CAPA root cause analysis. •Assisted in design control completion for a new minimally-invasive pedicle screw system.•Participated in multiple surgeon meetings, web conferences, and cadaver labs regarding a large scale pedicle screw system.•Provided feedback to consultants for new design control system during implementation. Worked with consultants to develop practical applications of the new design controls.

•Managed the logistics of an 800+ SKU PS Knee System including instrumentation; Managed cross-functional team members to progress manufacturing, quality, procurement and regulatory tasks as needed for product launch. Led multiple surgeon design reviews to steer the progress of the project, gather critical feedback, and balance expectations of surgeon team along with company goals. •Responsible for all implant models and prints, both catalogue and in-process. Worked closely with manufacturing engineer, casting vendor, and machining house to develop specifications for component fabrication. •Investigated product complaints to improve existing products as well as satisfy regulatory requirements for continuous sale of product. •Communicated directly with surgeons to develop design inputs for special instrumentation; completed Risk Analyses for special instrumentation to ensure safe and effective devices were provided to end user.•Regularly attended surgeries and cadaver labs to provide support to existing customers and continue my education of the medical device industry.

•Lead and managed a new project for knee implants and instruments to satisfy a market recently untapped by the company. Analyzed the mechanics of a licensed design to expand and improve upon the system to surpass other knee systems in the current orthopedic culture. System consists of a standard bank of over 150 implants in addition to instruments specific to the system for various surgical techniques. Responsible for casting, machined, and catalogue prints for femoral, tibial, insert, and patella components. •Developed an Instrument Upgrade for the EPIK Uni-compartmental Knee including Verification, Validation, and Manufacturing Transfer, which has allowed Encore to achieve a greater portion of the market share. New instruments were necessary for smaller incisions as well for more accurate femoral bone preparation, allowing the system to attract new surgeons as the Uni-Knee surgery has gained popularity.•Completed Manufacturer of Record Transfer for an acquired product line from OTI, including documentation and drafting transfers to incorporate into the Encore Quality System. Additionally, worked diligently to develop a set of special instruments for the acquired product line in order to retain one of the top volume surgeons in the company. •Delegated drafting and documentation requests to drafters and co-op students based upon capability and resource constraints. •Designed improvements to the 3D Knee System for tibial downsizing capabilities as well as femoral impaction instrumentation to meet international requests for a clearer and less complicated surgery. •Participated in FDA Audit to review and defend product complaint investigations as well as give direction to QA personnel regarding design control documentation. •Assisted in design control documentation for extension to existing hip line by developing inputs and verification documents for addition of HXL acetabular liners.