Project Manager II

o This position will focus mainly on our FDA remediation efforts, with potential remediation assistance on other upcoming audit streams.

On-site Role M-F

Managing multiple remediate projects

Experience with Power BI

Med experience no required but would be a nice to have



Project Leadership lead cross-functional project teams to deliver value stream optimization projects on time, within Product, 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.



All production is conducted with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP s), and Health and Safety requirements.



Qualifications:



Bachelor degree in Engineering, Science, Business,

2-5 years experience



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.



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



Create and maintain the project schedule. Identify and evaluate necessary resources. Communicate with team players and program manager. Report project status to program manager and upper management. Follow up on the project and task status. Qualifications: Bachelors Degree required, with preference for Mechanical, Bio-Mechanical Engineering. Minimum of 4-6 years of Project Management experience is required. Experience with product development process in medical device environment is preferred. Understanding of principles of product design and qualification within Medical Device industry. Strong analytical skills. Strong communication skills.