Led project management of Biomerics’ largest transfer program to date, resulting in 20 validated SKUs and $10M annual revenue. Created all documentation: DHF, DHR, WI, RMS, RMF, DDP, TM/TMV, IQ/OQ/PQ protocol & reports, memos, etc.Managed deployment of over 50 employees to accomplish ahead-of-schedule project completion.Supported two project-specific regulatory audits with no major findings.Initiated/improved operational systems to improve efficiency, traceability, & interdepartmental communication.

Utah Innovation Awards Finalist (2019)Managed a design project from concept to FDA 510(k) submission and design transfer of a new orthopedic implant for soft tissue-to-bone repairs. As lead engineer, I was responsible for all design, development, verification, risk management, regulatory, and quality activities. I also established a Project Management Office supporting additional company projects. Contributed on multiple patents.

Led product management and development for globally-distributed products combating water and air pollution. My work resulted in a 55% reduction in component cost and over $10M in new revenue to date (Q1 2020), as well as several industry-specific product awards. Specific responsibilities included: -Root cause analysis of customer complaints and product failures. -Direct component sourcing focused on product quality, experience, and consumer trends. -Train employees and independent representatives on technical advantages of product lines. -Manage sales strategy, promotions, and program development for the brand. -Negotiate supplier contracts and perform regular quality audits. -Research market trends and suggest new product categories. -Project management of product launches and sales campaigns.

Developed requirements, design concepts, and verification methods for childbirth simulation mannequins and life-saving neonatal resuscitators, leading to improved patient care in developing countries. Specific responsibilities included: -Mechanical design, prototyping, and testing of components. -Packaging design for electronic products destined for harsh environments. -Design, implementation, and reporting of validation and verification protocols. -Maintenance of existing products, including Engineering Change Orders within QMS. -Creation of marketing materials for product inserts, conferences, etc. -Opportunity exploration and definition for new projects. -Technical and business analysis of acquired technologies. -Risk management for regulated respiratory therapy devices. -Supervision of company-sponsored student projects.

User requirement exploration & definition for emerging projects.Business case development for potential internal projects.Digital concept creation for new outdoor products. Formal concept reviews with external clients.Human factors and aesthetic design of a laparoscopy instrument.

Designed and manufactured a new category of prosthetic feet, focusing on reducing production cost through material and process development, and improving amputees’ comfort and mobility. Specific responsibilities included: -Mechanical and aesthetic design of a low-cost prosthetic foot. -Establishment of technical specifications based on user requirements. -Verification testing according to ISO protocols. -Creation and maintenance of design history files. -Reduction of manufacturing costs by streamlining production processes. -Implementation of new engineering materials for weight and cost reduction. -Development of user guide and marketing materials.

Management of hardware and software maintenance and installation for over 1,000 end users. Development and maintenance of a secure academic examination solution for medical students.Design of a new interactive office space for IT professionals.Assistance with inventory management.Communication of issues and logistics with department heads.