Will Calkins Email & Phone Number

Denver, Colorado, United States

Denver, Colorado, United States

• Led cross-functional teams in developing advanced electromechanical medical device through the full product development lifecycle
• Managed technical aspects of projects, including risk assessment, requirements analysis, and verification and validation (V&V) while also executing tasks as an independent contributor
• Spearheaded system architecture design and integration, ensuring compliance with regulatory standards (ISO 13485, ISO 9001, FDA 21 CFR 820) and customer needs
• Conducted performance testing and analysis, leading to product improvements and enhanced user experience
• Assisted project management duties such as schedule updates, budget tracking and resource planning
• Provided mentorship and technical guidance to junior engineers, improving team capability and performance

Golden, Colorado, United States

• Led the creation of detailed CAD models and engineering drawings, ensuring high precision and quality
• Coordinated with suppliers and vendors to source materials and components, maintaining cost-effectiveness and quality
• Managed project timelines and budgets, ensuring on-time delivery and adherence to financial constraints
• Created and managed all DHF documentation for electromechanical medical devices from creating design inputs through completing verification and validation
• Implemented design for manufacturability (DFM) and design for assembly (DFA) principles, and created assembly documentation and manufacturing fixtures

Denver, Colorado, United States

• Led and executed design and manufacturing activities to launch the next generation of the CLMBR machine, including the creation of 3D CAD models, 2D drawings, FEAs, Tolerance Analyses, Process Documentation, and Design.
• Successfully delivered a fully functional tradeshow-ready prototype from 3D CAD and 2D drawings with a new contractmanufacturer in 5 weeks
• Managed a team of engineers through the product development process while promoting autonomy and growth
• Created all quality processes and documents followed by contract manufacturers in Taiwan and China, contributing to increased production metrics
• Provided service material and trainings to technical customer support team and “starred” in customer-facing assembly and service videos
• Developed and managed full machine high-cycle durability testing and various subassembly-specific static load testing

Denver, Colorado, United States

• Drove systematic improvements in manufacturing operations processes while producing electromechanical medical devices
• Led subassembly test development and execution to improve First Pass Yield on the production of all products
• Designed and implemented fixtures and assembly aids using CAD software (SolidWorks)
• Carried out process improvement, problem resolution, project management, and employee training
• Member of company-wide Continuous Improvement Team responsible for Lean training and implementation
• Led and presented company-wide Lean Trainings to Operations associates

Denver, Colorado, United States

• Performed a system-wide audit and remediation of all inputs, outputs, verification and validation procedures and reports for an automated blood-processing system as part of a design change
• Created and maintained engineering documents, tolerance analyses, inspection procedures, design history files and risk management documentation
• Managed and documented the results of early-phase testing of prototypes in an ongoing project

Austin, Texas

• Designed and developed implantable medical devices, surgical instruments, and point-of-use packaging using SolidWorks
• Served as Team Leader and Project Manager for a Lumbar Spine product line, qualification of a new external manufacturer, and redesign of point-of-use packaging project
• Conducted comprehensive Finite Element Analysis (FEA) on implants and instruments to optimize new product design, predict testing results, and justify revisions to products
• Created and maintained engineering prints, tolerance analyses, inspection procedures, design history files and risk management documentation for all product development projects
• Worked directly with external suppliers throughout the entire lifecycle of product design from concepts to production builds
• Experienced in Design for Manufacturability, Design for Assembly, prototyping, and statistical analysis of inspection data

Austin, Texas

• Designed and developed orthopedic implants and instruments using SolidWorks
• Experienced in implant and instrument design for Cervical Spine, Lumbar Spine, Knee, and Hip product lines
• Created engineering prints and worked with vendors to order functional prototypes and production parts
• Conducted Finite Element Analysis (FEA) on implants and instruments during the design process
• Led design review and design challenge meetings

Austin, Texas

• Project: Early Kick Detection Software - Dr. Scott Fish
• Utilized MATLAB to compile data, perform calculations, and produce graphs of predictive down-hole drilling behaviors
• Studied drilling dynamics and fluid behavior during all phases of the drilling process
• Created and presented status reports on a weekly basis to the research team