Aaron Owens Email & Phone Number

Minnetonka, Minnesota, United States

• Technical lead for a multi-site cross functional team of Quality, Regulatory, Manufacturing, and R&D developing new Class III catheters, introducers, and dilators for the treatment of atrial fibrillation via cardiac RF.
• Conducts research leveraging bench, porcine, and cadaver models for feasibility evaluation, specification development, and design validation.
• Creates product development documentation under FDA and EU MDR design controls (CFR 820, ISO 13485) to support the submission of 510(k) and PMA certifications. Collaborates on defining product requirements, aFMEAs &.
• Designs test methods and fixtures based on clinically relevant data to evaluate device performance in parallel with requirement creation. E.g. System performance, mechanical loading and durability, anatomical pathways.
• Leads design verification and validation activities. Writes and executes test protocols and reports documenting test procedure and equipment. Directs engineers, co-ops, and interns in the execution of design activities.
• Lead a product enhancement and cost reduction project for a cardiac cryo-ablation probe. Successfully launched 510(k) approved product realizing an annual savings of $300k.

Greater Minneapolis-St. Paul Area

• Technical lead for a multi-site cross functional team of Quality, Regulatory, Manufacturing, and R&D developing new Class III catheters, introducers, and dilators for the treatment of atrial fibrillation via cardiac RF.
• Conducts research leveraging bench, porcine, and cadaver models for feasibility evaluation, specification development, and design validation.
• Creates product development documentation under FDA and EU MDR design controls (CFR 820, ISO 13485) to support the submission of 510(k) and PMA certifications. Collaborates on defining product requirements, aFMEAs &.
• Designs test methods and fixtures based on clinically relevant data to evaluate device performance in parallel with requirement creation. E.g. System performance, mechanical loading and durability, anatomical pathways.
• Leads design verification and validation activities. Writes and executes test protocols and reports documenting test procedure and equipment. Directs engineers, co-ops, and interns in the execution of design activities.
• Lead a product enhancement and cost reduction project for a cardiac cryo-ablation probe. Successfully launched 510(k) approved product realizing an annual savings of $300k.

Eden Prairie, MN

• Led new product research and development. Worked across groups to create requirements, estimate expense, and generate concepts. Researched concepts via modeling, Design of Experiments, feasibility testing, and.
• Project examples: 3DCulturePro Perfusion Bioreactor, Enhanced Materials Test System, Integrated High Accuracy Displacement Sensor, and Cost Reduced Single Specimen Bioreactor.
• Conducted Advanced Development Research of potential technologies and innovations. Involved new sensor technologies, modeling performance, building prototypes, and feasibility testing.
• Directed project critical research such as Pressure Vessel Sealing with Hyper-Elastic Material Model, Elastomeric Grip Strain and Clamp Force, Noise Artifacts Analysis, Crosshead Clamp Contact Pressure and Stiffness.
• Trained Customer Service field engineers. Provided on-site installation and user training.

Eden Prairie, MN

• Led product development projects. Distilled marketing requirements to establish a project plan. Generated structural and modal analysis. Documented design, manufacture, and validated performance. Wrote specifications.
• Developed complete BioDynamic product line of tissue engineering bioreactors.
• Implemented automation component designs that reduced machined part costs 15%.
• Presented R&D contributions to entire division at quarterly reviews.

Minnetonka, MN

Designed Tissue Engineering bioreactors and test systems. Worked with manager to meet project milestones. Modeled and analyzed systems with Solidworks. Created prints, BOMs, and work instructions. Assembled and validated production systems.

United States

• Mechanical engineering internship involving design, testing, and validation of automation and distribution equipment for agriculture and road service industries.
• Mechanical design/drafting, and Electrical cable drafting with CADKey
• Design and performance evaluation of geared valves and cam driven switches.
• Measure of backlash, speed, and closure control performance.

Ames, Iowa

• Researching of Interactive Mesh-Free Stress Analysis methods at the Virtual Reality Application Center.
• Research academic literature for published mesh-free analysis methodologies.
• Meshing of closed form geometries, and geometries requiring a numerical solution.
• FEA with Abaqus to compare results of meshed, mesh-free, and theoretical solutions.

Mankato, MN

• Mechanical assembly of fiber optic cable blowers and related equipment.
• Reading assembly prints and routing instructions, pulling parts to bills of materials.
• Assembly of electro-mechanical systems, mechanisms, and bearings.
• Working with engineers problem solving part/print errors.