Anna Wing Email and Phone Number

Lead Clinical Engineer (R&D) and SME for TriClip Transcatheter Edge-to-Edge Repair (TEER) Products with extensive background and experience in valve repair therapies.

Support product development efforts for the MitraClip NT device as a key member of program teams by leading systems engineering tasks defining, developing and validating a smaller program or several features on a major program. Gather, understand, and analyze input requirements from stakeholders for new medical devices while supporting the instrumentation/service infrastructure. Translate information into specific system and device features.Perform technical planning and performance evaluation studies, conduct technology assessment activities, analyze system integration issues, generate initial baseline interface specifications, estimates costs and risk, and evaluate customer satisfaction through testing (alpha and beta), analysis and studies.Assign projects to specific teams and determine how systems will be architected and implemented. Provide guidance and leadership to teams as appropriate.Evaluate prototypes formally and informally through structured and ad hoc testing. Test aspects of new projects or algorithms to evaluate prototypes and validate output to meet intended use requirements.Provide input into the development of clinical system validation plans and the conduct of those tests.

Lead and direct a team of 5 engineers through the evolution of mechanical medical devices within the constructs of a strict design control process.Experienced in project management and planning, responsible for coordinating programs through the entire product life cycle from initial concept to final release. Facilitate cross-functional organization between inter-disciplinary teams such as manufacturing/process engineering, Regulatory Affairs, Quality Assurance, and Clinical Development to ensure all internal and external customer needs are met. Sustain engineering efforts for market released product, including changes for improved manufacturability, increased quality assurance, reduced cost, heightened product reliability and improved performance. Conduct product evaluations in an Operating Room environment, interacting with surgeons and surgical technicians to gain feedback and insight on how to better meet the customer’s needs. Deliver technical presentations and performed hands-on demonstrations quarterly to strengthen our sales force on a regular basis. Generate product Design Input documents for the developmental electrosurgical device, collaborating with the Clinical Development team to establish customer requirements, devices specifications, and project outputs. Approve and verify bill of materials, bill of documents, engineering drawings, and manufacturing processes at the component and device level. Delegate design and debug action items for developmental product, coordinating final design reviews to analyze entire device functionality and ensure specifications are met. Spearhead production tooling and manage procurement of materials to ensure a smooth, efficient transition from prototype phase to design transfer phase for product in development. Develop documentation required for FDA 510(k) submission including user needs analysis, human factors assessment, verification and validation protocols, and risk analysis.

Developed and created new product designs and detail using the CAD software SolidWorks. Extensive knowledge in design for manufacturability including machining, injection molding, and sheet metal stamping/forming. Designed, developed, and released a line of four trocar system devices to meet clinical and customer requirements for minimally invasive surgeries. Structured design verification test procedures, failure modes, and acceptance criteria. Constructed test fixtures necessary to evaluate performance. Designed and developed manufacturing fixtures that must be compatible with an ISO Class 8 clean room environment. Enhanced product design of a 5mm Laparoscopic Clip Applier through mechanism analysis and prototype fabrication. Swiftly implemented a design modification to mitigate an unforeseen hazard encountered in the field within a 2 month time frame of the first reported incident. Performed extensive product debug through in depth analysis of the device’s mechanical systems and manufacturing processes. Fabricated prototypes and experiment samples in order to replicate the malfunction, determine the root cause, and formulate cost-effective, time-sensitive solutions in efforts to reduce production downtime. Coordinated activities with vendor sales engineers and representatives to ensure off-the-shelf and custom components complied with engineering and quality specifications.Conducted material review reports for material non-conformances encountered during manufacturing operations. Implemented corrective actions to immediately address the incident batch and devised preventative solutions to ensure long term conformance. Evaluated returned product for Customer Experience Reports from the field. Cross-referenced the customer’s report of the incident and the engineering evaluation of returned unit to perform a root cause analysis and risk assessment of the malfunction.