Purpose of the Position:
The Project Manager is responsible for the design and implementation of the program management process, including building out the templates, tools and dashboards to support product development from feasibility to commercialization. Provides project management support of Product Development projects for new or improved molecular diagnostic products. Identifies and networks with multiple functional areas within the company expediting the product development process and successful commercialization. Accountable for delivering new products on spec, on time and on budget while meeting regulatory and company design control requirements. This role is the company champion and steward of the product development process.
Essential Duties and Responsibilities:
• Plans and drives execution of projects in Product Development and Product Technical Support. The projects may include clinical studies and regulatory submissions.
• Design the project management process; build out templates and tools for execution of the process.
• Creates the project plans for each product development effort, creates the tools to monitor and execute that plan.
• Applies advanced project management skills to assay and hardware, software and system projects.
• Tracks key deliverables against the design control process to meet project milestones. Works closely with quality and regulatory to ensure that the design control process is followed throughout the project.
• Establishes, maintains and communicates program milestones and timelines. Manages the program critical path including risk management and contingency planning. Assists management with resource planning.
• Executes assigned project tasks including technical and business work products.
• Provides effective leadership to the Core Team, ensures core teams meet deliverables, and serves as the “Program Ambassador”.
• Prepares and presents project status to senior management staff.
• Implements product development process improvements with the goals of meeting the Voice of the Customer, reducing project cycle times and meeting internal needs.
• Mentors and trains other employees to implement and improve standard product development and project management practices across the company. Socializes the discipline needed for project execution excellence.
• Provides an open environment and promotes teamwork across the organization. Acts as a catalyst to remove organizational barriers.
Key Qualifications & Experience Requirements:
• B.S. degree in the sciences, preferably Biochemistry, Microbiology, Molecular Biology, Analytical Chemistry or a related field. An advanced degree is desired. An MBA is a plus.
• Two or more years of experience in molecular diagnostic product development.
• Five or more years of experience and demonstrated success as a project manager for product development teams.
• PMP certification preferred.
• Uses professional concepts to contribute to meet the company strategic goals and to achieve personal objectives in creative and effective ways
• Strong organizational skills and ability to solve ambiguous situations.
• Strong presentation and influence skills.
• Ability to lead and influence in a matrix environment without direct authority over team members.
• Organizational, planning and detail follow-up skills required. Demonstrated ability to plan a project and execute to a timeline.
• Comfortable working in a fast-paced, dynamic environment while juggling multiple projects.
• Maintains broad knowledge of principles and best practices in molecular biology, clinical laboratories, biochemistry and instrument functionality.
• Experience in project management techniques for development of IVD products under an FDA regulated environment desired.
• Competency with project planning software required.
• IVD/Diagnostics experience preferred.