Manager, Clinical Research Engineering

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Additional Information

Primary Function of Position The Manager Clinical Research Engineering, Instruments will serve as a technical and clinical leader in the design and development of new product instruments and tool concepts, guiding programs from early concept through commercial launch. Leveraging deep clinical, scientific, and engineering expertise, this role will partner with engineers, physicians, interaction designers, human factors specialists, training teams, technical publications, and other internal and external stakeholders to shape product and procedural innovation. The Manager Clinical Research Engineering will lead clinical support for early-stage feasibility and confirmatory clinical studies, including proctoring, case observation, and synthesis of clinical insights to inform technology advancement. Responsibilities include identifying and documenting user needs, contributing to product requirements, assessing clinical risk, and providing design guidance throughout the Product Development Process (PDP). This role will also design, develop, and execute pre-clinical experimental strategies to evaluate device performance, safety, and usability, ensuring readiness for commercial launch. Working closely with regulatory, quality, clinical affairs, and finance teams. The manager Clinical Research Engineering will contribute to defining clinical indications, shaping commercialization strategies, and driving technologies from concept to market-ready products. Essential Job Duties Product Development Apply in-depth clinical knowledge and technical system understanding in defining and developing products based on clinical needs Collaborate with physicians and key clinical users on clinical procedure development and understanding product feedback Clearly define clinical need and requirements for product Develop test models and test methods for clinically relevant product evaluations. Assess potential clinical risks and propose mitigations as an input to product design Provide strategic leadership in both individual and team leader capacity for the design and development of new product concepts from early feasibility through commercial launch, leveraging deep clinical, scientific, and technical expertise. Leadership for team to conduct comprehensive research into disease states, procedural workflows, and emerging medical technologies to establish subject-matter expertise and guide innovation strategy. Partner with marketing, clinical, and physician stakeholders to define market needs and translate them into user-centric platform, procedure, instrument, and accessory designs. Lead and collaborate with engineers/CREs and clinicians to establish and validate clinical performance objectives, safety considerations, and usability targets for early-phase technologies. Architect, manage and execute clinical de-risking strategies-including pre-clinical and feasibility studies-to accelerate technology readiness and ensure robust clinical adoption potential. Manage structured design iteration cycles, incorporating internal evaluations and targeted feedback from key opinion leaders (KOLs) to refine concepts and mitigate risk. Define, manage and implement pre-clinical evaluation protocols to support regulatory submissions and first-in-human trials. Support regulatory teams in preparing submission-ready technical and clinical documentation. Apply a data-driven, analytical approach to identify opportunities for product enhancement and portfolio expansion. Clinical Research & Innovation Manage planning and execution of early-stage feasibility, pilot, and pivotal clinical trials to inform technology development, regulatory strategy, and reimbursement pathways. Identify, evaluate, and prioritize product enhancements and new product opportunities based on clinical needs, market trends, and physician feedback. Gather, analyze, and synthesize clinical insights from case observations and study data to refine product requirements, inform training programs, and proactively address clinical risks. Direct prototype evaluations in clinical environments, translating complex user feedback into actionable engineering requirements to accelerate development timelines. Drive the generation of intellectual property by conceptualizing novel clinical applications and technology innovations. Management Responsibilities Champion the organization's vision, values, and strategic priorities in all decision-making and cross-functional interactions. Consistently demonstrates culture and values of the organization internally and externally Hire, train and develop high performing staff, and support their long term professional development. Coach and provide feedback on an ongoing basis. Take ownership of high-priority, cross-disciplinary initiatives beyond core responsibilities to advance the company's strategic objectives. Required Skills and Experience Fluent in medical and procedural terminology with strong applied knowledge of human anatomy. Expertise in complex r

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Company Intel

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