Program Manager (R&D)

Tandem Diabetes Care•San Diego, CA

3d•$120,000 - $150,000•Hybrid

About The Position

The Program Manager (PM) leads cross-functional core teams and manages complex software projects and/or system-level programs through Tandem’s product development process, with the main goal of developing and delivering new medical device products to market. The Program Manager is expected to exemplify the program management function and capabilities within Tandem and external partners. Key elements of the function include: execution in a phase gate process that defines development team deliverables throughout the product life cycle, lead/participate in core and scrum meetings, establish and drive the team’s project plan and schedule with clearly defined core team roles and responsibilities, establish project metrics, execute PM responsibilities as defined by our Design Control procedures. The Program Manager is also expected to lead or participate in process improvement initiatives led by the PMO. Program Manager's at Tandem are also responsible for: Provides project management expertise and leadership to a multi-functional core team from Concept through Commercialization following Tandem’s standard process for product development and/or Design change; ensures implementation and compliance to Design Control procedures and improvements of systems, procedures, and documentation. Plans and directs all aspects of software/systems projects/programs. Establishes project plans and objectives, develops project cost analysis, establishes, and manages the project schedule and budget, manages resources, tracks progress, and provides updates to management and external partners. Works closely with the Program Office, Project Managers, and functional heads to resolve resource allocation issues, conflicts, and priorities and to ensure projects are staffed appropriately, completed on time, and within budget constraints. Ensures efficient transfer of product from R&D to manufacturing and external marketing. Leads/participates in process improvement initiatives related to product development, resource management and allocation, design controls, and other areas that impact cycle time, efficiencies, and compliance in medical device product development. Communicates and presents regular and timely project status updates to various levels of the organization including the executive management team and external partners. As necessary, performs other duties as required to support the PMO.

Requirements

Demonstrated success working in complex matrixed organizations and influencing cross-functional stakeholders.
Proven ability to drive cultural change and implement project management best practices.
Strong communication and executive-level influencing skills to manage scope, resources, and priorities.
Skilled at leading, motivating, and aligning project teams to meet schedule and business objectives.
Proficient with project management tools for planning, scheduling, task management, resource allocation, and collaboration.
Advanced Microsoft Office expertise, including Excel (formulas, pivot tables, dashboards/graphs), PowerPoint, and MS Project.
Experience with Engineering Change Orders (ECOs), documentation, and review processes.
Excellent written and verbal communication skills with the ability to build strong internal and external partnerships.
Strong organizational, prioritization, problem-solving, and decision-making abilities while maintaining confidentiality.
Knowledge of Agile/Scrum methodologies, product development processes, engineering principles, and medical device industry practices.

Nice To Haves

Bachelor’s degree in engineering or a related field; or a combination of education and applicable experience.
Certificate in Project Management (PMP) is desired. Alternatively, should be willing to pursue professional certification in the future.
Scrum Certification a plus.
4 years’ directly related experience in managing projects in FDA-regulated and ISO 14971 certified industry.
4 years’ experience in the medical device industry and compliance to internal Quality Systems.
Experience in managing projects from inception to post-market sustaining using a phase-gate methodology.
Experience in managing projects focused on solutions for people with diabetes a plus.
Knowledge and experience in the implementation of regulatory requirements for medical device development such as FDA’s Design Controls, ISO’s Risk Management and Medical Device standards, ISO Software Development standards (e.g., IEC 62304).

Responsibilities

Provides project management expertise and leadership to a multi-functional core team from Concept through Commercialization following Tandem’s standard process for product development and/or Design change; ensures implementation and compliance to Design Control procedures and improvements of systems, procedures, and documentation.
Plans and directs all aspects of software/systems projects/programs. Establishes project plans and objectives, develops project cost analysis, establishes, and manages the project schedule and budget, manages resources, tracks progress, and provides updates to management and external partners. Works closely with the Program Office, Project Managers, and functional heads to resolve resource allocation issues, conflicts, and priorities and to ensure projects are staffed appropriately, completed on time, and within budget constraints. Ensures efficient transfer of product from R&D to manufacturing and external marketing.
Leads/participates in process improvement initiatives related to product development, resource management and allocation, design controls, and other areas that impact cycle time, efficiencies, and compliance in medical device product development.
Communicates and presents regular and timely project status updates to various levels of the organization including the executive management team and external partners.
Performs other duties as required to support the PMO.