Business Process Improvement Specialist

2 days ago


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

Overview: Blue Star Partners LLC is seeking a Business Process Improvement Specialist to join our team as a Project Manager I. The ideal candidate will have experience with medical devices and working with cross-functional teams in science, lab, or clinical environments.

Key Responsibilities:

  • Direct the activities and personnel associated with small to large-scale projects, focusing on non-IT business applications and disciplines.
  • Manage all facets of single or multiple multidimensional projects through the Full Project Life Cycle.
  • 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.
  • Assign, guide, and monitor project staff, ensuring the successful execution of project tasks.
  • Deliver high-quality project solutions to business problems within defined budgets and timelines.
  • Provide expert project guidance and support proactively throughout the project completion.
  • Provide tracking, reporting, and presentations to management and users.
  • Demonstrate experience with medical devices and a strong understanding of clinicals, design controls, and regulated environments.
  • Lead cross-functional teams in science, lab, or clinical environments, leveraging excellent interpersonal skills and negotiation abilities.
  • Support IVDR compliance activities including the creation of technical files, post-market surveillance activities, and new product development documentation.
  • 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.
  • Preferred understanding of diagnostic assays.

Requirements:

  • Bachelor's degree in a relevant field.
  • PMP certification required.
  • 1-6 years of experience in project management.
  • Experience with medical devices and working with cross-functional teams in science, lab, or clinical environments.
  • Excellent interpersonal skills and the ability to negotiate effectively with team members.
  • Understanding of diagnostic assays preferred.

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