A cutting-edge biotech client in San Diego is looking to hire a Technical Program Manager to join their team. This person should have experience leading programs and effectively working with the cross functional program teams, to facilitate the development and completion of design control documents, integrating these activities and deliverables into the project plan. This role is key in instilling both technical and project management discipline, quality and best practices across all functions of the project.
What You'll Do:
Provide strong project management discipline and capability for all programs
Facilitate detailed project planning and timeline development to ensure product development alignment to corporate goals
Ensure that design controls and risk management activities, deliverables, and processes are integrated into the project plans and timelines
Lead cross functional project team meetings, publish minutes, and drive accountability and ownership across the core team
Establish clear roles and responsibilities within each project cross functional team
Ensure that product and system-level requirements are established, integrated, verified, and validated as part of the project plan and timeline.
Drive resource management and allocation process across the projects; provide the mechanism for collecting this information and maintain the resource database
Works with cross-functional department managers to resolve resource conflicts/priorities; improve the infrastructure and process for project resourcing
Works with the Quality organization to ensure that compliance is met for project and design history file documents
Proactively drives functional planning and project risk management
Establish and publish project dashboards and KPIs
Ensures the implementation of new standards on requirements and specifications development, management, and traceability on projects (e.g. Requirements Flow-down, Capabilities Flow-Up, CTQ's, etc)
Establish mechanisms for execution and communication of project metrics across all stakeholders
Ensure alignment and unified cadence to meet the project milestones
Skills We are Looking For:
Bachelor's Degree in an engineering discipline or equivalent training; MBA is a plus
8+ years' direct related experience in managing projects in an FDA-regulated industry
5+ years' experience in the medical device product development of Class II or III devices; combination products is preferred
Advance knowledge and experienced in the practical implementation and integration of FDA's 820 CFR and ISO 13485 in device development planning and execution.
Experience with design controls, risk management, and product realization
Experience managing projects from discovery to clinical trials and launch
Experience managing projects utilizing an IND regulatory and commercialization pathway. Knowledge of regulatory requirements for medical device development preferred (ISO 13485/MDD 93/42/EEc)
Strong presentation skills with the ability to communicate key project risks, milestones, KPI's to all levels of leadership within the organization
Strong technical background and understanding of engineering principles, methodologies and how they translate into a project plan
Experience in establishing technical documentation and design control deliverables
Advanced proficiency in the use of timeline applications such as SmartSheet, MS Project, Timeline Pro+
Advanced proficiency in standard applications such as Microsoft Office (i.e., Word, Excel, PowerPoint), Visio