Sr. Project Manager - Hardware

GROW WITH US:

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take a “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry.

STAY AWESOME:

Tandem Diabetes Care is proud to manufacture and sell the t:slim X2 insulin pump with Control-IQ technology. We’re also so much more than that. Our company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Since many of our own team members live with type 1 diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com.

A DAY IN THE LIFE:

The Sr. Project Manager manages the design and commercialization aspects of key new products with responsibility for driving collaboration of cross-functional product commercial teams. Acts as the internal liaison between engineering, marketing, manufacturing, RA/QA, and sales management for the purpose of scheduling projects, driving the timely launch of projects, budgeting resources, and reporting on the progress of several projects that are simultaneously being prepared for commercialization. Acts as a key facilitator in Tandem Product Commercialization Process (PCP) including facilitation of corporate Phase Review Discipline meetings and progress tracking with the Tandem Product Steering Committee (PSC). The Sr. Project Manager is also expected to lead or participate in product development continuous improvement projects led by the PMO.

• 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 when appropriate.
• Plans and directs all aspects of software/systems projects. 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. Works closely with the Product Management, Program 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.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
• Other responsibilities as assigned.

YOU’RE AWESOME AT:

• Requires a bachelor’s degree in engineering or equivalent training.
• 2 plus years’ experience managing projects in FDA-regulated and ISO 14971 certified industry.
• 2 plus years’ experience in the medical device industry and compliance to internal Quality Systems.
• 2 plus years’ experience in facilitating scrum ceremonies like sprint planning, sprint retrospectives and backlog grooming.
• Experience in managing more than one scrum team at a time.
• Experience in managing projects from inception to post-market sustaining using a phase-gate/agile methodology.
• 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.
• Proficient in JIRA and Confluence.
• 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