Intellectt Inc | Project Manager

3 weeks ago

mansfield, United States Intellectt Inc Full time

Job Title: Project Manager II

Location: Mansfield, MA 2048

Duration: 5 Months

Overview:

We are seeking a Project Manager II to lead and manage remediation projects, focusing on FDA remediation efforts and upcoming audit streams. The role requires on-site presence Monday through Friday. While medical device experience is not mandatory, it is highly desirable.


Key Responsibilities:

  • Project Leadership: Lead cross-functional teams to deliver value stream optimization projects on time, within scope, and budget.
  • Remediation Focus: Manage multiple remediation projects and assist with FDA and other audit-related initiatives.
  • Continuous Improvement: Apply Lean Six Sigma methodologies to streamline processes, eliminate waste, and enhance productivity.
  • Risk Management: Identify potential risks, develop mitigation plans, and address issues proactively to ensure project success.
  • Stakeholder Collaboration: Partner with maintenance, engineering, manufacturing, quality assurance, product development, process technology, and supply chain teams to align goals and execute projects successfully.
  • Performance Metrics: Establish and monitor KPIs to track progress, measure success, and drive continuous improvement.
  • Change Management: Facilitate smooth transitions and stakeholder buy-in for process changes.
  • Quality and Compliance: Ensure adherence to regulatory requirements, including GMP, Quality Systems Regulations, SOPs, and Health and Safety standards.


Additional Responsibilities:

  • Construct project timelines and monitor resources with oversight from senior program managers.
  • Provide regular updates on project status, performance metrics, and improvement initiatives to senior management.
  • Solve challenges within the project scope and ensure adherence to industry standards and best practices.
  • Utilize Power BI for data analysis and project reporting.


Qualifications:

Education: Bachelor’s Degree in Engineering, Science, or Business. Preference for Mechanical or Bio-Mechanical Engineering.

Experience:

  • 4–6 years of project management experience required.
  • Experience in a manufacturing environment, preferably in a medical device or FDA-regulated industry.
  • Familiarity with product development processes and principles of design and qualification in the medical device sector is preferred.

Certifications:

  • PMP certification preferred.
  • Lean/Six Sigma certification preferred.

Skills:

  • Strong analytical, organizational, and leadership skills.
  • Proficiency in Microsoft Office and experience with Power BI.
  • Excellent verbal and written communication skills.

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