Project Manager

Position: Project Manager

Location: Danvers MA

Position Description:

The Project Manager will play a key role in leading crossfunctional teams with the global IZiel support ensuring the seamless integration of MES (Manufacturing Execution System) software solutions. The aim is to foster innovation and streamline 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 includes 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 golive phase and ensure a smooth transition by promptly addressing emerging challenges.
• Conduct comprehensive reviews postimplementation 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/Preferred Qualifications:

• Bachelors or Masters 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.
• 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.
• Proficient in Microsoft Office suite (Word Excel PowerPoint etc.).
• Exhibit exceptional communication interpersonal analytical problemsolving and project management capabilities.
• Ability to work in both independent and collaborative team settings. Prepared to engage onsite with a diverse crossfunctional team including Quality Regulatory Manufacturing and Marketing departments.