Job Title: Project Manager

Location: Westbrook, ME

Contract Duration: Until EOY 2025 (with possible extensions)

Rate: $45 - $50/hr

Contract Type: W2 (Applicants must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. Blue Star Partners LLC will not sponsor applicants for U.S. work visa status for this opportunity — no sponsorship available for H-1B, L-1, TN, O-1, E-3, H-1B1, F-1, J-1, OPT, CPT, or any other employment-based visa.)

Overview:

We are seeking a Project Manager to support our client’s Infectious Disease – Lateral Flow division in Westbrook, ME. This role focuses on managing projects related to In Vitro Diagnostic Regulation (IVDR), overseeing complex project lifecycles, and ensuring on-time, within-budget delivery. The successful candidate will collaborate with cross-functional teams including Product Transfer, Regulatory, and Quality.

Key Responsibilities:

• Lead key initiatives in support of IVDR changes across internal teams and third-party manufacturers (TPMs).

• Collaborate across departments and international teams to drive project success.

• Facilitate effective meetings with goal setting, milestone tracking, and task delegation.

• Identify and resolve issues, mitigate risks, and develop actionable project plans.

• Manage multiple concurrent projects, ensuring timeliness and compliance.

• Ensure adherence to regulatory and quality standards throughout project execution.

• Utilize PFMEA to drive and document product change improvements.

Basic Qualifications:

• Associate’s Degree in Project Management or equivalent combination of education and experience.

• Minimum of 3 years of project management experience.

• Proficiency in Microsoft Office Suite including Excel, PowerPoint, Power BI, and Microsoft Project.

Preferred Qualifications:

• 1+ years of experience in a regulated environment.

• 1+ years in healthcare device or durable medical equipment manufacturing.

• Training or certification in Lean Six Sigma principles.

Key Competencies:

• Multitasking: Ability to manage multiple responsibilities efficiently and meet deadlines.

• Project Management: Skilled in organizing resources and leading project execution aligned with business goals.

• Innovative Thinking: Able to propose creative solutions and process improvements.

• Self-Motivated: Proactive in achieving personal and team objectives with minimal oversight.

• Communication: Excellent verbal and written communication, able to tailor messaging for varied audiences.