Apply deep technical expertise, systems thinking, and innovative problem‑solving to deliver complex medical device solutions. Develop and utilize internal and external relationships to develop innovative solutions. Serve as primary technical decision‑maker for system‑level architecture and across multiple workstreams. Lead the creation and execution of comprehensive technical plans, experimental strategies, and test methodologies. Drive structured experimental design to inform data‑based decision‑making and technical trade‑offs. Ensure integration of design performance, material selection, manufacturability, quality‑by‑design, and long‑term implant reliability. Identify, communicate, and mitigate technical risks through proactive planning and cross‑functional alignment. Provide clear and timely technical updates to stakeholders (Engineering Leadership, TRB, Tech Forums, PMM, PIB). Leverage internal R&D capabilities and external partners (suppliers, co‑development groups, academic collaborators) to advance development. Ensure appropriate engineering analyses—including modeling, characterization, verification, and systems evaluation—are applied effectively. Ensure compliance with quality systems, documentation standards, and design control throughout the PLCP lifecycle. Collaborate with program management, quality, process development, regulatory, clinical, and marketing. Build and maintain strong relationships with clinicians, internal experts, external stakeholders, and suppliers. Support resource planning to ensure appropriate staffing, skills, and budget utilization for technical workstreams. Maintain an external, forward‑looking perspective on industry trends, emerging technologies, competitive landscape, and clinical needs. Advance technical excellence by applying modeling, simulation, analytical tools, and engineering best practices. Drive continuous improvement in development efficiency, decision quality, and technical execution. Provide direction and mentorship to engineers and technicians in experimental design, technical approaches, and documentation. Promote best practices in engineering rigor, systems thinking, and innovation methodologies. Support conflict management and enable effective team dynamics in collaboration with functional leaders. Bachelor's or Master's degree in Mechanical, Biomedical, Chemical Engineering, or related field. 7-9+ years of engineering experience in medical device development, preferably in implants, delivery systems, or interventional technologies. Demonstrated ability to provide strong technical leadership for complex product development programs. Experience interacting directly with physicians and customers to inform design decisions. Proven problem‑solving skills with the ability to synthesize information from diverse sources and make sound decisions. Hands‑on engineering approach and experience across PDP phases from concept to commercialization. Excellent communication, documentation, collaboration, and organizational skills. Strong critical‑thinking skills and a flexible, solution‑focused mindset. Experience in exploratory/early feasibility development and identifying unmet clinical needs. Experience driving technical trade‑off decisions balancing performance, usability, manufacturability, cost, and reliability. Experience with structural heart medical devices. Knowledge of LAAC therapy, cardiovascular clinical workflows, and physician use environments.
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