Project Manager
7 days ago
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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