Project Manager I(Medical device)

Role: Project Manager I

Location: Westbrook, ME - 04092

Duration: 07 Months

RESPONSIBILITIES:

• Lead key initiatives and support the IVDR changes that are needed incollaboration with Product Transfer team, Regulatory, Quality, and otherdepartments.

• 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 successfuloutcomes.

• 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 potentialrisks and developing effective action plans to mitigate project delays.

• Efficiently manages multiple projects simultaneously, ensuring that alltasks 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 driveproduct changes, ensuring improvements are systematically identifiedand implemented to enhance product quality and reliability.

BASIC QUALIFICATIONS | EDUCATION:

• Associates Degree in Project Management or an equivilent combinationof 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.