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The Senior Project Manager is a key member of the value stream leadership team for Integra's Collagen Manufacturing Center (CMC) in Plainsboro, NJ. Reporting to the assigned value stream manufacturing manager, this position is responsible for leading cross-functional teams in the planning, direction and execution of site projects to drive efficiency, reduce waste and enhance overall performance to plan. This person will ensure clear communication with stakeholders in manufacturing, quality, engineering, product development, process technologies to ensure value stream performance. All production is to be conducted in compliance with ISO 7 and ISO 5 Clean Rooms and with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP's), and Health and Safety requirements.

SUPERVISION RECEIVED

Under the supervision of the value stream leader

SUPERVISION EXERCISED

No direct managerial supervision, indirect leadership for cross-functional project team members

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Project Leadership - lead cross-functional project teams to deliver value stream optimization projects on time, within scope, and on budget. Manage small, independent projects or specific workstreams within a large, complex program.

• Continuous improvement mindset and process improvement applying lead six sigma methodologies to streamline processes, eliminate waste and increase productivity for the assigned value stream.

• Risk Management - Identify potential risks and develop mitigation plans to address issues proactively and ensure project success.

• Stakeholder collaboration and communication, working closely with maintenance, engineering, manufacturing, quality assurance, product development, process technology and supply chain teams to align project goals and ensure successful execution. Provide regular updates to senior management on project status, performance metrics, and improvement initiatives.

• Participation in solving problems encountered within a project.

• Work with a cross-functional team to assign and track key project activities clearly communicating industry standards and best practice requirements to cross-functional teams.

• Constructing project timelines with refinement from value stream leadership, determining and monitoring resources to support a given project and building budgets with oversight from senior program managers

• Performance metrics & change management - establish and monitor key performance indicators (KPIs) to track progress, measure success, and drive continuous improvement. Facilitate change management processes to ensure smooth transitions and stakeholder buy-in for process changes.

• Quality and compliance - ensure all projects and processes adhere to regulatory requirements and industry standards for medical devices.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• Bachelor degree in Engineering, Science, Business, or equivalent with 5+ years of experience; Master degree with 2+ years of experience leading a team

• PMP certification preferred

• Experience leading cross-functional teams and project

• Experience in a manufacturing environment, preferably medical device or FDA regulated industry

• Must possess strong written, verbal and interpersonal skills.

• Demonstrated organizational and communication skills. Must possess strong leadership skills with team-focused attitude and approach.

• Strong computer skills, including Microsoft Office experience required.

• Demonstrated computer skills. Must be capable of working in an Oracle Enterprise Resource Planning (ERP) system. Database and quality data reporting experience required. Understanding of basic MRP process to control and complete work orders necessary.

• Must be able to gown into ISO 7 and ISO 5 Clean Room gowning.

• Understanding and experience with Lean/six Sigma, certification preferred

• Experience working in a chemical environment with a thorough understanding of the safety applications is required.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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