Project Manager

Job Title: Project Manager

Job Location: Westbrook, ME 04092

Job Duration: 8 Months

The position of Project Manager ­­­­­­­is within our Infectious Disease Developed Markets Business located in Westbrook, ME. This role involves managing projects related to In Vitro Diagnostic Regulation, overseeing all aspects of large-scale and complex projects from initiation to completion, and ensuring projects are completed on time and within budget.

This job description will be reviewed periodically and is subject to change by management.

RESPONSIBILITIES:

• Lead key initiatives and support the IVDR changes that are needed in collaboration with Product Transfer team, Regulatory, Quality, and other departments.
• Manages regular cadence of interaction between internal team and TPMs.
• Regularly collaborates with international employees and departments, effectively managing projects across diverse teams to ensure successful outcomes.
• Support business process improvement activities to continuously improve project deliverables.
• Ensures meetings are run with proper direction and helps set goals, milestones, and appropriate ownership of tasks with clear due dates.
• Proactively identifies and resolves issues, including recognizing potential risks and developing effective action plans to mitigate project delays.
• Efficiently manages multiple projects simultaneously, ensuring that all tasks are completed on time and within established deadlines.
• Ensures adherence to all relevant design and compliance requirements, maintaining high standards and regulatory compliance throughout the project lifecycle.
• Utilizes Process Failure Mode and Effects Analysis (PFMEA) to drive product changes, ensuring improvements are systematically identified and implemented to enhance product quality and reliability.

BASIC QUALIFICATIONS | EDUCATION:

• Associates Degree in Project Management or an equivilent combination of education and experience.
• 3 years’ experience in Project Management.
• Experience in Microsoft Suites software. (Microsoft Excel, PowerPoint, Power BI, Microsoft Project etc.)

PREFERRED QUALIFICATIONS:

• 1 years’ experience working in a regulated enviroment.
• 1 years’ experience in healthcare device manufacturing or durable medical equipment manufacturing
• Training or certification in Lean Six Sigma manufacturing principles.

COMPETENCIES:

• Multitasking: Demonstrates the ability to handle multiple tasks or responsibilities simultaneously by efficiently managing time, prioritizing tasks, and maintaining productivity across different activities.
• Project Management: Demonstrates the ability to achieve desired policy and program outcomes by planning, organizing, utilizing resources, and collaborating with peers to consistently delivering results aligned with departmental objectives.
• Innovative Thinking: Independently generates new, creative, and sometimes unconventional ideas to problem solve or improve current processes and structures while seeking feedback from managers and coworkers.
• Self-Motivated: Demonstrates a proactive attitude, consistently drives personal and team goals, seeks avenues of learning and growth, and maintains high productivity with minimal external supervision.
• Verbal and Written Communication: Effectively conveys ideas in both individual and group settings, adapting style and methods to suit the audience’s needs, both verbally and in writing.