Regulatory and quality auditor of medical device manufacturers on behalf of national governing bodies. Lead auditor for ISO 13485, MDSAP, MDD, ISO 9001, and MDR

Project Manager for independent startup $5 million farm helping to manage teams responsible for farm construction and facility implementation.

Development engineer and project manager of cross functional team responsible for development of multiple $150mil+ surgical instrument product lines.- Project Manager and team leader responsible for planning, coordinating, tracking, and reporting all product development activities- As project manage and development engineer led team sessions to define scope, requirements, assumptions, and risks of new project concepts- Managed the creation of marketing materials, roll out initiatives, sales forecasts, and inventory controls- Project manager responsible for development of project schedules- Gave bi weekly status report and risk mitigation plan updates to management- Trained and led teams of 5-10 engineers and technicians in performance testing- Enhanced qualification/verification testing protocols, reducing testing time by 25% - Produced concept updates, project reports, and training protocols for varying technical competencies - Generated submission reports and other documentation for FDA 510(k) and CE Mark submission

Engineer for orthopedic spinal implant start-up working to expand product portfolio.- Redesigned implants and instruments and updated product documentation for FDA submission- Caught fatal design flaw of inherited implant design- Led field service training of physicians- Performed market research to define customer requirements- Resolved manufacturing and engineering issues of existing product portfolio

Engineer in customs orthopedics group focusing on customer and patient needs for specially requested orthopedic instruments and implants up to $400k.- Collaborated with surgeons and sales reps to quickly design, develop, manufacture, perform quality assessment, and respond to post market feedback on custom 510(k) Class I orthopedic instruments- Related customer needs into design outputs- Led and prioritized 40 concurrent custom projects through a streamlined product development process- Attended surgeries and met surgeons in office in order to promote products, cultivate relationships, and close accounts with strategic customers- Coordinated RFQ bid responses and purchasing with customers, suppliers, and manufacturers - Tracked projects, maintained frequent communications with customers, and responded to post market feedback in order to maintain relationships and drive sales- Calmed upset customers, researched and resolved concens, and rebuilt trust preventing the loss of accounts- Reduced average project lead time from 5 to 3 months by creating accountability protocols for field sales reps, negotiating with management to reduce customer costs, and facilitating reduced manufacturing lead times- Updated regulatory, quality, and guidance policies and procedures to comply with and exceed FDA regulatory requirements

Correspondent responsible for cultivating stories for industry newsletter based on latest developments in the areas of pharmaceutical and medical device CMC, GMP, QbD, and regulatory for manufacturing trade publication.

Development engineer for orthopedic spinal implants and instrumentation from concept to commercialization while maintaining legacy product lines- Responsible for development activities, tracking, and reporting all product development pipeline activities- Led product launch planning, design of marketing material, and strategic roll out of new product lines- Performed market research and helped establish sales forecasts- Provided in-service and on site training to surgeons and sales reps on proper instrument use- Streamlined costs of manufacturing by updating designs of legacy system, reducing manufacturing cost by 15%- Attended industry trade shows to promote product portfolios- Verified, responded to, and resolved customer complaints

- Designed and tested new techniques to determine muscle activity and output- Served as teaching assistant and adviser to undergraduates

- Developed injection molded, minimally invasive, single use instrument and implant - Created and implemented protocols for engineering studies and performed design verification and validation testing- Performed market research on customer data in preparation for clinical studies

Substitute teacher responsible for class instruction and student well being