Supervisory Biomedical Engineer (Clinical)
Veterans Health AdministrationVA X_Labs is a specialized innovation incubator designed to accelerate high-tech, personalized Veteran care. Originally launched at VA Puget Sound in 2020, it partners with academia and industry to bring advanced manufacturing into everyday clinical operations. The incumbent plays a critical role to plan, develop, and influence customer discovery and engagement activities surrounding the potential development of medical devices and other emerging technologies utilized in health care.This position is aligned under the Office of the Deputy Director, receiving supervision from the Chief of X_Labs (Formerly known as VA Ventures). The incumbent will achieve assigned professional objectives that supplement the core objectives to fulfillrequirements for the Biomedical Engineering Career Field. FUNCTION OR SCOPE OF ASSIGNED DUTIES: Participate in medical device product development projects as the portfolio management representative, guide the team on alignment with strategic goals of the project. Advise development team on how customerrequirements influence the product development process and ensure that design verification activities confirm the design output meets the design input for the project and that design validation activities are appropriate to show through objective evidence that the devices developed meet user needs. Create and implement processes for portfolio tracking, including oversight of selection and monitoring and evaluation of pilot technologies and special initiative projects. Review systems to ensure proper documentation, fidelity, and post-pilot assessments are conducted, guaranteeing initiatives are managed in alignment with portfolio management best practices and VA priorities. Develop VHA enterprise-level criteria and procedures for medical device design development, testing, manufacturing, and deployment, ensuring Veterans receive treatments with the highest levels of safety and efficacy. Collaborate with clinical staff members in the design and development of medical devices, and must be capable of comprehending surgical approach, patient anatomy, and potential complications that might impact the safety and efficacy of the device. Likewise, must be able to communicate engineering and regulatory principles in a manner understandable by clinical staff. Ensure all documentation, including electronic records, comply with standards for quality management and data security in alignment with medical device regulations. Integrate lessons learned and stakeholder feedback into future initiatives and maintain repository control over all pilot project documentation and outcomes. Act as a subject matter expert and strategic influencer for the identification, pilot, and potential roll-out of emerging medical technologies and special initiatives. Demonstrate deep clinical insight, enabling translation of clinical workflows and needs into actionable designrequirements and project inputs. Actively engage and communicate with multidiscipl
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