Christina Reed Email & Phone Number

Irvine, California, United States

Irvine, California, United States

• Manage a team of employees and oversee clinical development activities such as procedural development, clinical education, case support, and patient screening• Oversee the development of instructions for use (IFU), physician and clinical specialist training documents, and patient screening procedures for early clinical studies• Interact with external key opinion leaders, imaging professionals and core labs to support procedure development, patient screening, and patient follow up• Interact with R&D engineering teams to support animal studies, troubleshoot procedural issues and guide device design changes• Develop interactive and collaborative relationships with clinical trial investigators

Irvine, California

• Provide on-site, real-time guidance during clinical implants and document procedural case observations for learning and training updates• Provide clinical design inputs and collaborate with product development teams to provide feedback on device iterations and new device development• Develop and implement pre-clinical test strategy and provide guidance to team members on strategy execution• Design, prepare and conduct First In Human product evaluations, including some case support for proper product use and feedback collection• Develop, review, and update clinical design control documents including technical summaries, design validation protocols and reports, design and application FMEAs• Develop procedural techniques for FIH and early clinical studies, including creation of IFU and physician training materials• Develop patient selection criteria and manage patient screening process for FIH and early clinical studies• Collect and analyze data from early human use studies and perform literature/competitive reviews

West Coast

• Serve as clinical expert in the use of GE interventional imaging systems and advanced software applications for all clinical segments (Structural Heart/IC, EP, Neuro, HOR/Vascular Surgery, IR/IO)• Lead clinical discussions and product demonstrations during the sales cycle• Train physicians and clinical staff on the use of GE interventional imaging systems and advanced software• Provide onsite clinical support to customers during complex cases within the cath lab and OR environment• Assist with customer satisfaction issues, specialty training requests, and onsite technical troubleshooting • Manage relationships with Key Opinion Leaders and develop customer reference sites • Support KOLs in the creation of case studies and presentations for congresses• Build clinical content for marketing and provide feedback to engineering through customer support• Demonstrate product features and advanced software to customers at congresses/tradeshows

• Lead a team of engineers in developing a new line of surgical devices, while maintaining responsibilities from previous role as a product development engineer• Research clinical studies, MAUDE reports, and market data to understand evolving clinical needs• Observe surgical cases and meet with surgeons to obtain design input• Set up animal labs for product performance testing• Work closely with QA, RA and clinical/marketing teams to meet project deliverables• Participate in recruitment activities such as candidate interviews, career fairs, and company tours

• Work within a team to design and develop multiple products from concept to production release• Collaborate with clinical development team to understand customer needs• Design concepts and fabricate prototypes for early development testing• Optimize designs for manufacturability (injection molding, machining, stamping, MIM, etc.)• Work with production and process engineering teams to implement manufacturing processes• Build relationships with suppliers while sourcing new materials and equipment• Perform and document all product development activity per Applied’s quality management system and design control procedure (complying with ISO 13485, ISO 14971, MDD, and 21 CFR, Part 820)• Manage project timeline and provide regular program updates to management• Develop test protocols and perform bench top and animal lab testing• Attend surgical cases with sales team during product design validation testing

Endosurgery, R&D

Endosurgery, R&D

Endosurgery, R&D