Senior Technical Project Manager

Role Overview

• Manage day-to-day execution of multiple projects/workstreams and supporting strategies using standard project management tools and practices.
• Lead cross-functional teams to deliver high-quality solutions on time and within budget.
• Maintain clear and consistent communication with both internal and client stakeholders, providing regular project updates and status reports.
• Create project plans and schedules and provide budgetary input for new development projects.
• Develop clear and attainable project objectives, build project requirements, and manage the constraints for projects (cost, time, and scope).
• Maintain and track project team performance to targets and metrics.
• Provide accurate and timely reporting on resource utilization, spending and budgets, schedule and deliverable status, and project risks, etc.
• Plan resource requirements and negotiate team resource assignments with functional managers within a matrixed engineering organization.
• Manage sub-contract and partner resources.
• Track progress to requirements and plan; resolve deviations and mitigate project risks.
• Conduct successful project, programmatic, and design reviews; inform stakeholders and leadership of unanticipated or potential issues/concerns as soon as they are known, proposing solutions and trade-offs to achieve successful project outcomes.
• Participate in and contribute to development of project scope, approaches, plans and estimates.
• Provide accurate and timely project reporting.
• Manage and drive compliance to FDA, regulatory and standards requirements.
• Manage and drive compliance to PMO best practices and QMS policy and procedures.
• Contribute to continuous improvement in project management best practices and processes.
• Lead project scope and estimate development in collaboration with engineering and account management resources.
• Motivate and organize project execution teams; negotiate and resolve personal/team conflicts and project/functional conflicts.
• Drive successful execution and achievement of project and business goals.
• Lead the creation of project plans, including budget and resource planning, to develop and commercialize innovative and complex products and systems employing software, hardware, robotics, and other technologies.

Requirements

• 10+ years of successful experience in managing and leading full product development lifecycle projects.
• Experience with complex medical device technologies (FDA Class 2/ 3 highly desired), IVD, life science instrumentation, or robotics is preferred.
• Track record of leading multi-disciplinary engineering and technical teams, hardware/software integration is preferred.
• Knowledge of Waterfall and Agile development; strong understanding of the application of Agile development methodologies to regulated product development preferred.
• Must be a skilled and determined communicator and negotiator.
• Ability to manage multiple projects/workstreams simultaneously.