Chris Justice Email & Phone Number

Leawood, Ks, Us

Prairie Village, Kansas, Us

We create medical devices. Our creative engineering team is a booster rocket for accelerating the design of medical devices and high technology systems. We help clients launch products with certainty. Our clients include top-10 medical device companies and startups alike. We are systematic designers who believe in rapid iteration. Our team has a great sense of urgency and ownership. We are a growing company and we invest in people, tools and infrastructure. Nearly all Engenious projects come to us by referral. Follow developments on our LinkedIn company page.

Proximate Medical focused on solving problems with medical device alarms management, medical device networking and interoperability. We help institutions and busy clinicians provide higher-quality healthcare. Our technology enables low-cost connectivity to virtually all medical devices including therapeutic and diagnostic monitors, reduces clinician workload, removes barriers between patient and caregiver for higher-quality healthcare experience while reducing healthcare institution costs and preventable injury Scales across institutions and brings data from the patient to medical device manufacturers.

Grew engineering team from 12 to over 50 full-time professionals. Tripled revenue. Steadily and significantly increased profit margins. Established and maintained ISO:13485 certification through many audits. Developed leaders and changed culture.RBC Medical is a design engineering firm focused on the design of Class II and Class III medical devices. Typically embedded electro-mechanical systems that diagnose or treat medical conditions. The devices commonly contain software of Moderate and Major level of concern software as classified by FDA with 510(k), PMA and CE Mark approval paths. Recent clients include 7 of the top 20 med device firms in addition to startup and established mid-sized companies.

Us

Technology start up company bringing novel identification systems to market. Multi-million dollar funding. Responsible for on-schedule product development of production and lab animal ID systems using dermal tattoo implant, chip-free RFID, applicators and readers. Technologies included needle-free jet injection, needle injection, dielectric sensing, GHz imaging systems, injectable colloidal suspensions (inks).

Manage medical device development. In-vitro diagnostics, therapeutic, surgical, single-use & clinical lab devicesResponsible for schedule, budget, risk managementOversee Electrical circuit design, implementation, documentation, test and manufacturing transitionOversee Software design, implementation, test and documentation of safety-significant embedded software Oversee mechanical engineering, industrial design, test and documentationOversee verification and validation testingEvaluate, select, and manage suppliers and contract manufacturers (domestic & international)Safety agency approval interface (UL, TUV, VDE) and EMC troubleshooting. Highly familiar with IEC 60601 safety requirements for medical devices and collateral standards.Develop systems & improve procedures to meet the needs of FDA GMP guidanceCompile & maintain Design History File, issue tracking and documentation to a level adequate for medical devices and to comply with quality system

- Electrical circuit design, implementation, documentation, test and manufacturing transfer for electronic products.- Embedded software design.- Design team member, independent engineer or team lead depending on scope of project.

- Engineering Intern, assisted with electrical and software design and test of PC architecture hand held computers, peripherals. - Schematic entry, circuit design, embedded software design and troubleshooting.- Authored DOS/Windows driver test software and embedded microcontroller software.