Krista Joyce Camero Email & Phone Number

San Marcos, Ca, Us

Escondido, California, Us

• Led a project team in expanding the product line by executing project plans, strategically assigning tasks, and facilitating effective meetings, employing essential project management tools. • Coordinated with medical professionals, conducting in-depth meetings with doctors and extensive user needs research to develop product specifications. • Conducted thorough research on 3D printing vendors, while performing comprehensive cost analysis to inform the strategic procurement of 3D printers. • Participated in continuous improvement initiatives to enhance product development processes. • Communicated with suppliers and external partners to source materials and components for production.

• Designed and 3D printed a compact and secure cryptocurrency atm.• Defined and assessed product specifications, hardware requirements, and manufacturability concerns.• Selected materials and internal electrical components.

• Assisted in the development of a magnetic compression medical device.• Developed a quality management system for the manufacturing of the device.

Abbott Park, Illinois, Us

• Initiated an average of 150 complaints per week for cardiac rhythm management devices.• Determined if complaints are reportable or nonreportable to the FDA and ensured that device history record had complete information and are properly escalated if necessary.

Newport Beach, Ca, Us

• Achieved 510(k) clearance from the FDA for three product lines.• Assisted the regulatory team with 510(K) submission and created documentation for additional information requested by the FDA. • Completed Design History File documentation including project management plan, detailed drawings, biocompatibility reports, and risk management plan. • Improved process for verification and validation testing saving material and manufacturing time and costs. • Proposed, generated, and routed engineering change orders for drawings and documentation.• Engaged in all phases of the design process for multiple projects and led design review meetings with a cross functional team.• Collaborated with the manufacturing team to prototype and manufacture dental implant assemblies at high volume.• Performed FEA studies and tolerance analysis on assemblies and components.• Became the go-to expert for troubleshooting issues with the dental CAD software and provided continuous support for the production team.

Rancho Santa Margarita, Ca, Us

• Redesigned an enclosure for simulating a minimally invasive surgery environment.• Designed a mold for a developing product and created a thermoforming apparatus to test the materials in various conditions.• Created and routed engineering change orders for new and existing products.