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Project Manager I

2 months ago

Santa Clara, California, United States Blue Star Partners LLC Full time

{"h1": "Project Manager I Job Description", "p": "At Blue Star Partners LLC, we are seeking a highly skilled Project Manager I to oversee the activities and personnel involved in small to large-scale projects. The successful candidate will have a strong understanding of clinicals, design controls, and regulated environments, as well as experience working with cross-functional teams in science, lab, or clinical environments.", "ul": [{"li": "Direct the activities and personnel associated with small to large-scale projects, focusing on non-IT business applications and disciplines."}, {"li": "Manage all facets of single or multiple multidimensional projects through the Full Project Life Cycle."}, {"li": "Collaborate with project sponsors, business units, and users to identify project scope and focus, develop project initiatives, and implement project requirements, plans, processes, and tools."}, {"li": "Assign, guide, and monitor project staff, ensuring the successful execution of project tasks."}, {"li": "Deliver high-quality project solutions to business problems within defined budgets and timelines."}, {"li": "Provide expert project guidance and support proactively throughout the project completion."}, {"li": "Provide tracking, reporting, and presentations to management and users."}, {"li": "Demonstrate experience with medical devices and a strong understanding of clinicals, design controls, and regulated environments."}, {"li": "Lead cross-functional teams in science, lab, or clinical environments, leveraging excellent interpersonal skills and negotiation abilities."}, {"li": "Support IVDR compliance activities including the creation of technical files, post-market surveillance activities, and new product development documentation."}, {"li": "Perform on-market support tasks such as regulatory impact assessments and regulatory operations including BUDI number updates, label reviews, FDA laser reports, and state manufacturing licenses."}], "h2": "Requirements", "ul": [{"li": "Bachelor's degree in a relevant field."}, {"li": "PMP certification required."}, {"li": "1-6 years of experience in project management."}, {"li": "Experience with medical devices and working with cross-functional teams in science, lab, or clinical environments."}, {"li": "Excellent interpersonal skills and the ability to negotiate effectively with team members."}, {"li": "Understanding of diagnostic assays preferred."}]}