Program Manager (Hardware)

Tandem Diabetes Care•Ruth, CA

4d•$120,000 - $150,000•Hybrid

About The Position

The Program Manager (PM) leads cross-functional core teams and manages complex hardware 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 hardware/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

Ability to work in matrixed environment, establishing a sphere of influence with both the functional and vertical organizations.
Ability to drive cultural change through implementation of best practices in project teams.
Ability to communicate and influence up in order to manage project scope and resources.
Ability to keep project teams focused, motivated, creatively work to keep the projects on schedule.
Proficient in the use of Project Management Tools for planning, work breakdown, scheduling, task estimation, and collaboration.
Advanced Microsoft Office skills: Excel: Forms, Formulas, Functions, Pivot Tables, & Graphs; PowerPoint: Graphics & Animation; MS-Project: Resource loading, tracking ECO writing/review.
Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties including Company management and outside business associates.
Ability to interact with executive management on a regular basis.
Ability to represent Tandem at professional and business functions in a competent manner.
Excellent advocacy and persuasive skills.
Ability to maintain confidentiality.
Ability to organize and prioritize workflow and to meet established timeframes.
Ability to maintain updated knowledge of products, procedures and of changes within the medical device industry.
Ability to provide feedback and suggestions for improvement on the Product Development Process.
Ability to assess a problem quickly and determine to what level it should be elevated, directing staff/customers to the correct person(s).
Knowledge of agile/scrum development methodology.
Strong understanding of engineering principles, theories, and concepts.
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.
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).

Nice To Haves

Bachelor’s degree in engineering or a related field; or an equivalent combination of education and applicable experience.
Certificate in Project Management (PMP) is desired. Alternatively, candidate should be willing to pursue professional certification in the future.
Experience in managing projects focused on solutions for people with diabetes a plus.

Responsibilities

Leads cross-functional core teams and manages complex hardware projects and/or system-level programs through Tandem’s product development process.
Develops and delivers new medical device products to market.
Executes in a phase gate process that defines development team deliverables throughout the product life cycle.
Leads/participates in core and scrum meetings.
Establishes and drives the team’s project plan and schedule with clearly defined core team roles and responsibilities.
Establishes project metrics.
Executes PM responsibilities as defined by Design Control procedures.
Leads or participates in process improvement initiatives led by the PMO.
Provides project management expertise and leadership to a multi-functional core team from Concept through Commercialization.
Ensures implementation and compliance to Design Control procedures and improvements of systems, procedures, and documentation.
Plans and directs all aspects of hardware/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.
Ensures 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.