Project Manager- Danver, MA - Intellectt INC

Hiring: Project Manager
Location: Danvers, MA.
Duration: 12+ months
Visa Requirements: Any Visa

JOB DESCRIPTION:

The Project Manager will be instrumental in leading cross-functional teams with the global support to ensure the seamless integration of MES software solutions, fostering innovation, and streamlining processes within manufacturing operations.

POSITION RESPONSIBILITIES:

• Lead project teams and offshore engineering talent in collaboration with organization leadership to achieve successful MES software deployment.
• Craft comprehensive project plans, establish timelines, and allocate budgets for MES implementation. This involves setting clear project goals, specifying deliverables, and determining necessary resources.
• Actively involve all stakeholders throughout the project lifecycle to ensure alignment and address concerns.
• Thoroughly comprehend the unique requirements of manufacturing operations and effectively translate them into MES system specifications.
• Vigilantly monitor project progression, adeptly manage potential risks, and swiftly resolve issues to maintain project integrity.
• Provide robust support during the MES go-live phase and ensure a smooth transition by promptly addressing emerging challenges.
• Conduct comprehensive reviews post-implementation to extract valuable insights and identify areas for continuous improvement.
• Undertake other related tasks as assigned by project leadership to support the overarching project goals.

DESIRED QUALIFICATIONS:

• Bachelor's or Master's degree in Engineering, Project management or any other science discipline.
• Proficiency in MS Project.
• PMP certification preferred.
• Minimum of 5 years of project management experience, preferably within the medical device sector or a similarly regulated industry.
• Have a solid understanding of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and other pertinent regulations and standards.
• Prior experience at a manufacturing site is advantageous but not mandatory.
• MES experience is highly desirable.
• Be proficient in Microsoft Office suite (Word, Excel, PowerPoint, etc.).
• Exhibit exceptional communication, interpersonal, analytical, problem-solving, and project management capabilities.
• Ability to work in both independent and collaborative team settings. Be prepared to engage onsite with a diverse cross-functional team, including Quality, Regulatory, Manufacturing, and Marketing departments.