Project Manager I - Blue Star Partners LLC

Job Title: Project Manager I
Location: Santa Clara, CA – onsite – local candidates only
Period: 09/02/2024 to 09/01/2025 – possibility of extension
Hours/Week: 40 hours – hours over 40 will be paid at time and a half
Rate: $45 - $50/hour
Contract Type: W-2 only

 
Scope of Services:

The Project Manager I is responsible for overseeing the activities and personnel involved in small to large-scale projects, with a primary focus on non-IT business applications and disciplines. This role involves managing all aspects of single or multiple multidimensional projects throughout the Full Project Life Cycle. The Project Manager I will collaborate with project sponsors, business units, and users to define project scope, develop project initiatives, implement project plans, assign and monitor project staff, and ensure the success of projects. They will deliver high-quality project solutions to business problems within defined budgets and timelines, providing expert guidance and support throughout the project lifecycle. Experience with medical devices is essential, including a good understanding of clinicals, design controls, and working in a regulated environment. Additionally, experience with cross-functional teams in science, lab, or clinical environments is required, along with demonstrated leadership skills and excellent interpersonal abilities. The Project Manager I will also support IVDR compliance activities including the creation of technical files, post-market surveillance activities, and on-market support such as regulatory impact assessments and operations like BUDI number updates, label reviews, FDA laser reports, and state manufacturing licenses.

 
Role, Responsibilities, and Deliverables:

• 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.

 
Experience:

• 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.