Kelly Rasmussen Email and Phone Number

Hardware Subject Matter Expert (SME). Provided innovative mechanical designs, identified issues, did root cause analysis, and provided succinct solutions. Created project plans, schedules, budgets, and delivered to milestones. Established device requirements including Medical Standards. Wrote Standard Operating Procedures; created templates for: drawings, validation plans, quality plans, and Trace Matrix. Wrote test protocols and reports for V&V. Redesigned our Flagship Systems:•… Show more Hardware Subject Matter Expert (SME). Provided innovative mechanical designs, identified issues, did root cause analysis, and provided succinct solutions. Created project plans, schedules, budgets, and delivered to milestones. Established device requirements including Medical Standards. Wrote Standard Operating Procedures; created templates for: drawings, validation plans, quality plans, and Trace Matrix. Wrote test protocols and reports for V&V. Redesigned our Flagship Systems:• NexSys, Plasma Collection System: redesigned the key module (Blood Separation Centrifuge) on our main device. Reduced part count: from 69 to 31; build cost: from $2,689 to $1,600 (savings $5M/ yr.); reduced service cost: from $4k to $148 (savings: $8M/ yr.); made subsystems modular/ replaceable; increased simplicity, stability, and reliability.• Centrifuge Production Transfer (from external to internal manufacturing): was lead engineer for design transfer activities including: 1) Drawing Remediation: CTQ dimensions, DFM changes for new/ local vendors; 2) Redesign and Qualification of components with known issues; 3) Qualification of Off-the-Shelf (OtS) components to replace costly custom ones; 4) Review/ approval of: work instructions (WIs), quality/ inspection plans, & first article inspection (FAI). • Platform Combination & Modernization: combined four main devices into one standard platform with four options. Took the best aspects of each type of component and modernized designs to incorporate strengths and eliminate weakness. Components included: separator, sensors (optical, laser, ultrasound); valves, pumps, filters, & weighers. Show less

R&D of minimally invasive surgery (MIS) for Spine—focusing on surgical visualization. Principal for camera design, prototyping, and testing; also for, equipment design, assembly, surgical support, validation, and vendor selection/approval. • Camera Design, Prototyping, & Testing: Selected or developed: sensors, lenses, mounts, housings, shielding, illumination, and electrical connections. Designed light delivery and diffusion systems for multi-color laser and white LED illumination.… Show more R&D of minimally invasive surgery (MIS) for Spine—focusing on surgical visualization. Principal for camera design, prototyping, and testing; also for, equipment design, assembly, surgical support, validation, and vendor selection/approval. • Camera Design, Prototyping, & Testing: Selected or developed: sensors, lenses, mounts, housings, shielding, illumination, and electrical connections. Designed light delivery and diffusion systems for multi-color laser and white LED illumination. Assisted in lens cleaning system design. Designed tubing, electrical cabling, strain relief, and optical fiber termination. Optimized camera: size, illumination, surgical cleaning, and interference immunity. • Optical Lab & Specialized Equipment Setup: Setup the lab and purchased or designed equipment including: laminar flow bench; lens assembly, focus/ aligning, and affixing tools; light characterization, optimization, and diffusion testing equipment; light fiber termination and polishing tools; fiber and cable over-molding equipment. • Surgical Lab Support: Constructed cameras and equipment for surgeons to use in developing new procedures. Was active in labs: wrote test protocols, recorded results, captured suggestions, wrote and presented reports. • DFM, Quality, Regulatory Compliance & Vendor Selection: Led and participated in DFM studies. Established quality procedures, documents, and templates compliant with medical regulation. Created: work instructions, inline inspection instructions/ log sheets, incoming inspection plans/ reports, and validation plans. Wherever possible external suppliers were used to augment staff. Researched, selected, vetted, and managed suppliers. Show less

PDP/ Company Policy streamlining and simplification; New Business development; Regulatory burden minimization; Quality Inspection and Validation documents/templates; EPDM Administration. US and China.• PDP: Refined/simplified verification and validation policy (EV, DV, PV) and wrote protocol templates/test plans. Simplified document submission/acceptance criteria so it wasn’t opinion based but regulatory requirement based.• New Business: St. Jude Cardiac Mapping/Ablation:… Show more PDP/ Company Policy streamlining and simplification; New Business development; Regulatory burden minimization; Quality Inspection and Validation documents/templates; EPDM Administration. US and China.• PDP: Refined/simplified verification and validation policy (EV, DV, PV) and wrote protocol templates/test plans. Simplified document submission/acceptance criteria so it wasn’t opinion based but regulatory requirement based.• New Business: St. Jude Cardiac Mapping/Ablation: designed several push/pull locking connectors with: optical fibers, data lines, and isolated power. Provided form/fit/function prototypes for medical device shows. Covidien Sequential Compression: designed push button locking connectors with: pneumatic lumens and data lines for counterfeit prevention and use limiting. SnapRay (SnapPower): redesigned the product including: electrical contacts, insulation, insertion guides, and the optical sensor.• Regulatory Compliance, Quality, & Inspection: Established standards, procedures, documents, and templates compliant with medical regulation. Trained production to the new procedures and logged training. Created: Work Instructions, Inline Inspection Instructions/Log Sheets, Incoming Inspection Plans/Reports, and Validation Plans.• EPDM (Product Data Management): Helped select, deploy, and administer ATL’s Document Control Vault. (Standards/Rules/Templates for: parts, assemblies, drawings, specifications, and all quality documents.)• Sustaining Engineering: Medrobotics Flex System: transferred production in-house due to quality issues with suppliers. Did root cause analysis of pervasive optical fiber issues & developed a quality in-house process. Show less

Product Development. Project Management. Engineering Services. - Ideation, Engineering, & Qualification of New Designs - Contract Development of: devices, products, and goods.Examples:• HydroSleeve: Hydration Pack for Runners. Hands Free Armband Hydration System incorporating an innovative angled bite valve. Designed and positioned so that drinking is as easy as lifting your bicep to your mouth. https://www.hydrosleeve.com/• LocCap: Container Cap Compartment to… Show more Product Development. Project Management. Engineering Services. - Ideation, Engineering, & Qualification of New Designs - Contract Development of: devices, products, and goods.Examples:• HydroSleeve: Hydration Pack for Runners. Hands Free Armband Hydration System incorporating an innovative angled bite valve. Designed and positioned so that drinking is as easy as lifting your bicep to your mouth. https://www.hydrosleeve.com/• LocCap: Container Cap Compartment to store/hide useful items. (See animation below.)• SkullBolt Medical Device: developed a quick to market, 3D printed, product based on customer input. This simple device replaced popsicle sticks and tape to support/secure a neurological sensor used to monitor pressure in head trauma/pathology for both short and long term treatment.• TMJ/ Snoring/ Sleep Apnea Mitigation Device: developed a Mandibular Advancement Device that positioned the jaw to elevate TMJ, snoring, and sleep apnea while resting. Product was US designed and produced in China. Supervised validation and assisted in the creation of FDA documentation. • Arterial and Vascular Access Demonstration Models: produced large acrylic models of arterial and vascular systems for product demonstration purposes at medical device shows. These laminated acrylic models included body artwork and routed pathways that guidewires, catheters, stents and retrieval devices could be inserted into for head-to head testing against competing products. Show less

Capstone gives graduating engineers two semesters experience with real, industry-sponsored projects. I coach a team of raw recruits through BYU’s Product Development Process. We deliver a crafted solution including: prototypes, finished goods, and intellectual property.• Mentoring: Performance evaluation, Project Scope Management, and Team Leadership Assignment.• Instruction: CAD, Design, and Best Engineering Practices.• Project: NOV Hydrocyclone (dynamic fluid… Show more Capstone gives graduating engineers two semesters experience with real, industry-sponsored projects. I coach a team of raw recruits through BYU’s Product Development Process. We deliver a crafted solution including: prototypes, finished goods, and intellectual property.• Mentoring: Performance evaluation, Project Scope Management, and Team Leadership Assignment.• Instruction: CAD, Design, and Best Engineering Practices.• Project: NOV Hydrocyclone (dynamic fluid separator, oil and gas exploration): Replaced a $200,000 centrifuge with a $8,000 controlled hydrocyclone—see report.• Project: Jershon Ladder (new generation, advanced composites): Replaced heavy, clunky, legacy ladders with sleek new ones. Reduced weight from 68 to 42 lbs. Added a smooth extension mechanism. Worked with another team to Incorporate an auto leveler for uneven ground—see report. Show less

Plan and direct product improvement and process development. Provide technical guidance in design, testing, manufacturing, and V&V of new product lines.• Envy (Green) Laser Cavity: Redesigned current laser reducing system cost from $1,650 - $250; size from a boot box to a deck of cards; component count and assembly time by half; power consumption by 66%. Improved reliability and MTBF over x10; co-invented novel Bond in Place ports; developed tooling to align, tune, and fix in place… Show more Plan and direct product improvement and process development. Provide technical guidance in design, testing, manufacturing, and V&V of new product lines.• Envy (Green) Laser Cavity: Redesigned current laser reducing system cost from $1,650 - $250; size from a boot box to a deck of cards; component count and assembly time by half; power consumption by 66%. Improved reliability and MTBF over x10; co-invented novel Bond in Place ports; developed tooling to align, tune, and fix in place laser optic components.• Array Scanning Laser Link: Team created of the best pattern generating ophthalmic laser delivery system on the planet. NPI focus: design for producibility, production tooling, qualification, work instructions, verification, validation, finalizing BOMs, and personnel training.• Vision One: Refined our flagship (and most expensive) laser system. Resolved design flaws in appearance and function of the system structure and skin. Evaluated new thermoforming technology. Delivered simple solutions to chronic production problems with the form, fit, and function. Reduced rework of cast components by 50% and production costs by 15%. Will reduce system costs by 40% (in process). • PLM Implementation Team: Enovia (by Dessault): team setup, configured, tested, and qualified the company’s new document control and storage system. Transferred years of legacy data and verified it as complete and accurate via statistical testing. Show less

Project management of high volume production machines; planning, scheduling, machine performance specifications, acceptance tests, and qualification protocols.• External Projects: Automated projects too large for in-house development. Machines produce implantable, class II, medical devices. Projects incorporated: robotics, cam systems, pallet & conveyor systems, indexers, bowl feeders, pick & place, cryo-forming, and corona treating.• Hydrophilic Guidewire Automation… Show more Project management of high volume production machines; planning, scheduling, machine performance specifications, acceptance tests, and qualification protocols.• External Projects: Automated projects too large for in-house development. Machines produce implantable, class II, medical devices. Projects incorporated: robotics, cam systems, pallet & conveyor systems, indexers, bowl feeders, pick & place, cryo-forming, and corona treating.• Hydrophilic Guidewire Automation, Ireland: Machines produce the best nitinol guidewire in medical. Equipment: nitinol thermal setting, plastic co-extrusion, RF tipping, chemical conditioning and neutralization washing. (ISO standards, CE Mark, metric parts, international equipment shipping and travel). • Digital Balloon Inflation Device: Developed equipment and supervised qualification of: embedded circuit post processing, programing, & testing; UV curing; and Leak Testing.• Introducer Post-forming Automation: Developed a high capacity thermal forming machine that produced 10,000 surgical introducers / shift of various materials & lengths for overmolding.• Valved Peritoneal Drainage Needle: Developed most of the equipment to produce this line: ultrasonic welding, dispensing, leak testing, pad printing. Some equipment qualification.• CAD Administrator: Managed International Vault: budget, hardware, software, training, and beta testing. Evaluated, purchased, and deployed Merit’s PDM system (SolidWorks EPDM). Show less

Product Design: Development of Class II, Implantable, plastic medical devices.• Groshong Catheter: Complete FDA design submission & patent. Developed the proximally trimmed, distally valved version of Bard’s flagship silicone micro catheter. Development cycle included: market input, competitive metrics, concept generation and selection; finite element analysis; prototyping, testing, and injection mold design.• Power Port & ISP Port: Complete PD & NPI of plastic, type II… Show more Product Design: Development of Class II, Implantable, plastic medical devices.• Groshong Catheter: Complete FDA design submission & patent. Developed the proximally trimmed, distally valved version of Bard’s flagship silicone micro catheter. Development cycle included: market input, competitive metrics, concept generation and selection; finite element analysis; prototyping, testing, and injection mold design.• Power Port & ISP Port: Complete PD & NPI of plastic, type II device. Optimized design via DOE to: seal septa, minimize needle coring, perfect ultrasonic joint, and reduce mold shrinkage. Developed overmolding of plastic and titanium insets, injection molding stack, and all ultrasonic joining equipment.• Various Plastic Class I & II Medical Devices: (Valved Introducers, Feeding Ports, and Pleural Peritoneal Drainage Devices.) Used FEA to test failure modes, developed test equipment to collect SPC data, modified product design to minimize costs, and developed production equipment for: RF tipping; thermal forming; gluing; and ultrasonic joining. Wrote control documents, protocols, performance specifications, and IQ, OQ, & PQ. Show less

Product Design (High Strength Composites & Plastics): Development of product line & production equipment.• “Tuff & Lite” Fiberglass Ladder Line ($1.6 m): Extension ladders, multi-function ladders, step ladders: Developed the complete line. The designs won awards for product appeal, functionality, and affordability. Designs optimized weight, strength, impact toughness, and product cost.• Manufacturing Equipment: Developed, programed, and supported ladder production equipment… Show more Product Design (High Strength Composites & Plastics): Development of product line & production equipment.• “Tuff & Lite” Fiberglass Ladder Line ($1.6 m): Extension ladders, multi-function ladders, step ladders: Developed the complete line. The designs won awards for product appeal, functionality, and affordability. Designs optimized weight, strength, impact toughness, and product cost.• Manufacturing Equipment: Developed, programed, and supported ladder production equipment including: • Ladder rail cutting/notching saws. • CNC rung hole routing station.• Aluminum rung sawing station. • Manual & pneumatic rung presses.• Ladder assembly tables & fixtures. • Squaring, gluing, & drying jigs.• Composite curing ovens. • Cyclic testing machines & Go/No-go gauges. Show less

C-17 Globemaster III ($218 m): USAF Tactical Transporter and Airlifter.• Design Correction Engineering: Tested aircraft design and manufacturing process to pinpoint production errors, redesigned the aircraft or process to correct problems, wrote ECOs to Aircraft Industry and Department of Defense standards. • Engineering Covered: airframes, power plants, electrical and hydraulic systems, and materials review.Production Technology, Detail Fabrication (Boeing 747, 757… Show more C-17 Globemaster III ($218 m): USAF Tactical Transporter and Airlifter.• Design Correction Engineering: Tested aircraft design and manufacturing process to pinpoint production errors, redesigned the aircraft or process to correct problems, wrote ECOs to Aircraft Industry and Department of Defense standards. • Engineering Covered: airframes, power plants, electrical and hydraulic systems, and materials review.Production Technology, Detail Fabrication (Boeing 747, 757, 767): Composites Production Equipment:• Production Automation: Developed a six-axis robotic extrusion saw and a rapid-ply-cutter (automated, multi-layer, composite lay-up, nesting, and cutting table).• Production Tooling: Developed NC drills, auto-aligning presses, resin-injectors, thermocouple production stations, and specialized processes to improve production.• SPC Integration: Developed digital equipment to collect statistical data. Integrated SPC into Tail Section Production. Revised processes that were out of statistical control. Show less

IC Chip Carrier Production Equipment:• Full Chip Production Lines: Developed complete lines of integrated circuit chip carrier production equipment: • Ceramic slurry mixing vessels. • Substrate lay-up & curing tables.• Substrate slicing and scoring equipment. • Substrate automatic fracturing equipment. • Laminated-chip edge-routers. • System maintenance equipment.