Catridge Development ManagerDescription - Provides direct and ongoing leadership for an organization of multiple individual contributors designing and developing engineering solutions for a microfluidic cartridge for molecular POCT or other IVD Diagnostic products. Closely collaborates and fosters collaboration of the team with the instrument, assay and system integration teams as well as with the cartridge operations team. Manages headcount, deliverables, schedules, and costs for the cartridge development programs, ensuring that resources are appropriately allocated and that goals, objectives, timelines, and budgets are met in accordance with program and organizational roadmaps. Works with Q&R to ensure compliance with HP200A’s QMS, particularly making sure the team is properly trained and all equipment used for development is properly classified. Engages with the program head, marketing, supply chain, technical leaders and executives to communicate program status, escalate issues, and guides and influences strategic decision-making. Proactively identifies opportunities for process improvement and cost reductions opportunities for development spend as well as for cartridge COGS. Provides overall people-care management for direct reports, including hiring, setting and monitoring of annual performance plans, coaching, and career development; drives and fosters organization-wide performance standards, expectations, and practices to support ongoing team member and process development. Begins to provide strategic input to design, develop, optimize, qualify, validate, and transfer Medical Diagnostic Device Solutions (Instruments, Cartridges and Consumables). Begins to build up Medical Device team and develop talents and promote teamwork orientated initiatives and operational excellence. May serve as an owner or contributor to corrective and preventive action (CAPA), Nonconformance, and Change Control Provides input into the development of changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed. Participates in compliance audits as required. REQUIREMENTS: Educational background: A master's or PhD In bioengineering, biomedical engineering, chemistry, or a related field. Equivalent industry experience may also be considered. Experience: Minimum of 7 years of experience in cartridge development, with at least 3 years in a managerial or leadership role, ideally in the field of IVD POCT Technical skills: Proficiency in microfluidics, assay development, polymer science, and familiarity with IVD regulatory standards and requirements. Leadership abilities: Proven track record of leading and developing high-performing teams, strong decision-making skills, and the ability to drive projects forward. Communication skills: Excellent communication, presentation, and interpersonal skills, capable of effectively conveying technical concepts to both technical and non-technical stakeholders. Problem-solving: Strong analytical and problem-solving skills, with the ability to innovate and adapt to changing project needs. Adaptability: Comfortable working in a fast-paced, dynamic environment, able to prioritize tasks and manage multiple projects simultaneously. Job -EngineeringSchedule -Full timeShift -No shift premium (United States of America)Travel -Relocation -Not SpecifiedEEO Tagline - HP Inc. is EEO F/M/Protected Veteran/ Individual with Disabilities.
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