Work Flexibility: Onsite

Who we want

• Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management, and leadership teams.

• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

• Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

What you will do

• Assume overall responsibility for the successful initiation, planning, design, execution, monitoring, controlling and closure of a project.
• The Sr. Project  Manager is responsible to the project stakeholders for delivering a project’s objectives within scope, schedule, cost, and quality.
• Lead capital acquisition activities for the project, including machine, equipment, tooling, fixture vendor selection, purchase, installation, validation and hand off to operations.
• Define and clarify project scope while developing and maintaining the project schedule. Take ownership for managing and reporting project progress.
• Work closely with Product Development, Advanced Technology and Global Marketing to drive successful project implementation. Actively engage with Manufacturing Operations to evaluate existing process layouts in terms of new process integration, ensuring best utilization of floor space, minimized handling and optimum process flow within the project.
• Participate in the selection, training and performance appraisal process of project resources, including temporary contract SMEs as required for the project.
• Responsible for identifying, monitoring, and appropriately managing project risk.
• Monitor and control progress of work within the project, ensuring sound application of engineering principles and the appropriate use of policies and procedures.
• Analyze equipment to establish operating data, conduct experimental test and analyze results. May lead or act as independent reviewer in process review meetings specific to the project.
• Select components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols within the project.
• Ensure adherence to GMP and safety procedures within the project framework.
• Review and approval of validation documentation specific to the project.

What you need

• Bachelor’s degree in an engineering discipline
• 7+ years of experience in a technical or project management role
• Demonstrated ability to define project risk and to effectively manage project risks
• Demonstrated experience with Microsoft products - Excel, Access, PowerPoint, MS Project required
• Excellent attention to detail and interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams
• Excellent analytical skills, ability to plan, organize and implement concurrent tasks
• Demonstrated Leadership, Project Management and Engineering experience in New Product Introduction in a regulated environment.
• Experience in an FDA regulated industry.
• Experience of GD&T, process mapping, statistical methods and process/product validations
• Experience with plastic injection molding. Validation of parts.
• Experience with automated assembly equipment.
• Experience dealing with automated equipment suppliers
• Experience leading construction and utilities installation.
• Bilingual: English & Spanish

Travel Percentage: 20%